Bausch and Lomb Moisturizing All Clear

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When are you taking this medicine?

Bausch and Lomb Moisturizing All Clear uses

Bausch and Lomb Moisturizing All Clear consists of Benzalkonium Chloride, Naphazoline Hydrochloride, Polyethylene Glycol.

Benzalkonium Chloride:


Pharmacological action

Bausch and Lomb Moisturizing All Clear is an antiseptic. This medication is a quaternary ammonium compound, belongs to the cationic surfactant. Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) has antimicrobial and antiviral activity against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex Type 2, Staphylococcus aureus, little active against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) is not active against Mycoplasma spp.

This medicine exerts spermicidal action which is due to the ability to damage the sperm membrane; inhibits sperm motility, disrupting electrolyte balance of the aqueous phase of cervical mucus.

Pharmacokinetics

Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) for external and local application is practically not absorbed.

Why is Bausch and Lomb Moisturizing All Clear prescribed?

For external use only. Topical solution - a primary and delayed primary wound treatment, prevention of secondary infection of wounds hospital strains of microorganisms (injury of soft and bone tissue, burns), festering wounds, drainage of bone cavities following surgery for osteomyelitis.

Weight thick - superficial thermal burns, trophic ulcers, long-unhealed wounds of soft tissues (including infected), pyo-inflammatory skin diseases and diabetes mellitus; paraproctitis.

Tablets and capsules for intravaginal use, vaginal suppositories, creams, tampons - local contraception for women of reproductive age: for the presence of contraindications to the use of oral contraceptives or intrauterine devices, in the postpartum period, lactation, after the termination of pregnancy in premenopause period at irregular sexual life, omission or delay in receiving consistently used oral contraceptives.

Liquid concentrate - disinfection of facilities and medical products.

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Dosage and administration

Topically. The solution was diluted with distilled water to make 1% aqueous solution, impregnated gauze dressings, napkins or tampons and put on the wound daily.

Mass is applied at the rate of 0.2-0.4 g/cm2 of wound surface, pre-clean the wound from the purulent discharge, necrotic tissue, or impose gauze or use turundas impregnated with drugs. The maximum daily dose is 50 g. Ligation is carried out daily, the course of treatment is 14 days.

Intravaginally. Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) entered deeply into the vagina before coition; in case of repeated sexual intercourse it should be re-imposition of tablets, capsules, suppositories, creams; tampon can be removed not earlier than 3 h after the last sexual intercourse but no later than 24 hours after its installation (with repeated sexual acts for 1 day shift tampon is not required).

Concentrate Liquid. Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) used for disinfection after prior dilution with water.

Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) side effects, adverse reactions

Contact dermatitis, candidiasis, vulvovaginal and allergic reactions.

With prolonged use of Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) it is possible a local irritation.

Bausch and Lomb Moisturizing All Clear contraindications

Hypersensitivity to Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride), contact dermatitis, malignant neoplasm of the skin; for intravaginal use - coleitis, ulceration and irritation of the mucous membrane of the vagina and uterus.

Using during pregnancy and breastfeeding

Bausch and Lomb Moisturizing All Clear has no negative impact on pregnancy. This medicine is not excreted in breast milk and it can be used during lactation.

Special instructions

To improve the efficiency it requires careful observance of the application method. Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) can be used in conjunction with a vaginal diaphragm or intrauterine device. You should avoid bathing or irrigation of the vagina with soapy water for 2 hours before and within 2 hours after sexual intercourse (this medication is destroyed by soap), outdoor toilet is only possible with clean water.

Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride) is incompatible with soaps and other anionic surfactants as well as citrates, iodides, nitrates, permanganates, salicylates, silver salts and tartrates.

Bausch and Lomb Moisturizing All Clear drug interactions

Any substance introduced intravaginally can reduce local spermicidal action (including soaps and solutions containing it). Iodine solutions inactivate Bausch and Lomb Moisturizing All Clear (Benzalkonium Chloride).

Naphazoline Hydrochloride:


VASOCON REGULAR

Bausch and Lomb Moisturizing All Clear (Naphazoline Hydrochloride) OPHTHALMIC SOLUTION USP, 0.1%

Naphazoline HCl, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. The active ingredient is represented by the structural formula:

Chemical Name:2-(1-naphthylmethyl)-2-imidazoline monohydrochlorideVASOCON REGULAR ophthalmic solution is a sterile solution containing 1 mg/mL Bausch and Lomb Moisturizing All Clear (Naphazoline Hydrochloride) in an isotonic solution containing polyethylene glycol 8000, sodium chloride, polyvinyl alcohol, edetate disodium and purified water; preserved with benzalkonium chloride. Hydrochloric acid and/or sodium hydroxide added to adjust pH. It has a pH of 5.5 to 7.0.CLINICAL PHARMACOLOGY

Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha adrenergic receptors in the arterioles of the conjunctiva resulting in decreased conjunctival congestion. Naphalozine belongs to the imidazoline class of sympathomimetics.

INDICATIONS AND USAGE

Bausch and Lomb Moisturizing All Clear (Naphazoline Hydrochloride) REGULAR is indicated for use as a topical ocular vasoconstrictor.

CONTRAINDICATIONS

Contraindicated in the presence of an anatomically narrow angle or in narrow angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.

WARNINGS

Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.

PRECAUTIONSGeneral

Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, ocular infection or injury and when other medications are being used.

Patient Information

Patients should be advised to discontinue the drug and consult a physician if relief is not obtained within 48 hours of therapy, if irritation, blurring, or redness persists or increases, or if symptoms of systemic absorption occur, i.e., dizziness, headache, nausea, decrease in body temperature, or drowsiness.

To prevent contaminating the dropper tip and solution, do not touch the eyelids or the surrounding area with the dropper tip of the bottle. If solution changes color or becomes cloudy, do not use.Drug Interactions

Concurrent use of maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug..

Pregnancy Category C

Animal reproduction studies have not been conducted with naphazoline. It is also not known whether naphazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.

Nursing Mothers

If is not known whether naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established. See “WARNINGS” and “CONTRAINDICATIONS”.

ADVERSE REACTIONSOcular

Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.

Systemic

Dizziness, headache, nausea, sweating, nervousness drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.

DOSAGE AND ADMINISTRATION

Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.

HOW SUPPLIED

Bausch and Lomb Moisturizing All Clear (Naphazoline Hydrochloride) REGULAR (naphazoline hydrochloride ophthalmic solution USP, 0.1%): 15 mL plastic squeeze bottle with dropper tip. NDC 58768-844-15 To be dispensed only in original, unopened container. Store at controlled room temperature 15°-30°C (59°-86°F).

CAUTION: Federal law prohibits dispensing without prescription. Mfd. by OMJ Pharmaceuticals, Inc.,San Germán, P.R., 00683 for:CIBA VisionOphthalmics®_Atlanta, Georgia 301556072-A

Polyethylene Glycol:



One Gallon

For Gastrointestinal Lavage Rx only

DESCRIPTION: Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)® with flavor packs is a colon lavage preparation provided as water-soluble components for solution. In solution this preparation with one flavor pack delivers the following, in grams per liter.

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) 3350 60.00
Sodium chloride 1.46
Potassium chloride 0.745
Sodium bicarbonate 1.68
Sodium sulfate 5.68
Flavor ingredients 0.851

When dissolved in sufficient water to make 1 gallon, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) 3350. The reconstituted solution is isosmotic and has a mildly salty taste. This preparation can be used without the flavor packs and is administered orally or via nasogastric tube.

Each orange flavor pack (3.22 g) contains hypromellose, natural and artifical orange powder, saccharin sodium, colloidal silicon dioxide. Each lemon lime flavor pack (3.22 g) contains, hypromellose, natural and artifical lemon lime powder, Prosweet® Powder Natural, saccharin sodium, colloidal silicon dioxide. Each cherry flavor pack (3.22 g) contains hypromellose, artifical cherry powder, saccharin sodium, colloidal silicon dioxide.

CLINICAL

Pharmacology: Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)® with flavor packs cleanses the bowel by induction of diarrhea. The osmotic activity of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) 3350, in combination with the electrolyte concentration, results in virtually no net absorption or excretion of ions or water.

INDICATIONS AND USAGE: Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

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CONTRAINDICATIONS:

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) is contraindicated in the following conditions:

  • Gastrointestinal (GI) obstruction
  • Bowel perforation
  • Gastric retention
  • Ileus
  • Toxic colitis or toxic megacolon
  • Known allergy or hypersensitivity to any component of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)

WARNINGS: Flavor packs are for use only in combination with the contents of the accompanying 1 gallon container. No other additional ingredients (e.g., flavorings) should be added to the solution. Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs should be used with caution in patients with severe ulcerative colitis.

PRECAUTIONS:

General: Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of Bausch and Lomb Moisturizing All Clear ® with flavor packs, especially if it is administered via nasogastric tube.

Serious Fluid and Serum Chemistry Abnormalities

Advise patients to hydrate adequately before, during, and after the use of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol), consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Fluid and electrolyte abnormalities should be corrected before treatment with Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol).

In addition, use caution when prescribing Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) for patients who have conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmia, and renal impairment.

Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

Seizures

There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizures cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution with prescribing Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia.

Renal Impairment

Use caution when prescribing Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

Colonic Mucosal Ulcerations and Ischemic Colitis

Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) may increase the risk. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease (IBD).

Use in Patients with Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). Use caution in patients with severe active ulcerative colitis.

Aspiration

Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Such patients should be observed during administration of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol), especially if it is administered via nasogastric tube.

Not for Direct Ingestion

The contents of each jug must be diluted with water to final volume of 4 liters (4L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.


If gastrointestinal obstruction or perforation is suspected appropriate studies should be performed to rule out these conditions before administration of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)® with flavor packs.

Patient Counseling Information:

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)® with flavor packs produces a watery stool which cleanses the bowel prior to examination.

For best results, no solid food should be ingested during the 3 - 4 hour period prior to the initiation of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs administration. In no case should solid foods be eaten within 2 hours of drinking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs.

The rate of administration is 240 mL (8 fl. oz.) every 10 minutes. Rapid drinking of each portion is preferred rather than drinking small amounts continuously.

The first bowel movement should occur approximately one hour after the start of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs administration.

Administration of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs should be continued until the watery stool is clear and free of solid matter. This normally requires the consumption of approximately 3-4 liters (3-4 quarts), although more or less may be required in some patients. The unused portion should be discarded.

Consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.

Drug Interactions:

Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities

Use caution when prescribing Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizures, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate in patients taking these concomitant medications.

Potential for Altered Drug Absorption

Oral medication administered within one hour of the start of administration of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies to evaluate carcinogenesis or mutagenic potential or potential to adversely affect male or female fertility have not been performed.

Pregnancy: Category C. Animal reproduction studies have not been conducted with Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) to evaluate the carcinogenic potential. It is not known whether Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) in pediatric patients have not been established.

Geriatric Use: Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrate on chest x-ray after vomiting and aspirating PEG.

ADVERSE REACTIONS: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.

To report suspected adverse events contact Meda Pharmaceuticals Inc. at toll free 1-888-317-0001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION: Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one hour waiting period after the appearance of clear liquid stool should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs administration.

Oral: The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes (see PRECAUTIONS, Information for Patients ). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3-4 liters (3-4 quarts).

Nasogastric Tube: Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs is administered at a rate of 20-30 mL per minute (1.2-1.8 L/hour).

Preparation of Bausch and Lomb Moisturizing All Clear with flavor packs Solution:

This preparation can be used with or without flavor packs.

  • To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. Discard unused flavor packs.
  • SHAKE WELL to incorporate flavoring into powder.
  • Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No other additional ingredients, e.g. flavorings, should be added to the solution.)

Note: If not using flavor packs, omit steps one and two above.

HOW SUPPLIED: Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs is supplied in 1 gallon bottles with an attached package containing flavor packs. Each 1 gallon bottle contains Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) 3350 227.10 g, sodium chloride 5.53 g, potassium chloride 2.82 g, sodium bicarbonate 6.36 g, sodium sulfate (anhydrous) 21.50 g. Each preparation is supplied in powdered form, for oral administration as a solution.

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) with flavor packs 1 gallon NDC 68220-133-01

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS.

DISCARD UNUSED PORTION.

Rx only

Manufactured for:

Meda Pharmaceuticals Inc.

Somerset, NJ, USA

Manufactured by: Kremers Urban Pharmaceuticals Inc., Seymour, IN 47274

For Medical Inquiries,

Call toll-free 1-888-317-0001

NDC 68220-133-01

REV 08/ 2013

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Medication Guide

Colyte® (co-light) with Flavor Packs

(peg-3350 & electrolytes for oral solution)

Read this Medication Guide before you start taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) can cause serious side effect, including:

Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:

  • abnormal heartbeats that can cause death
  • seizures. This can happen even if you have never had a seizure.
  • kidney problems

Your risk of having fluid loss and changes in body salts with Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) is higher if you:

  • have heart problems
  • have kidney problems
  • take water pills (diuretics) or non-steroidal anti-inflammatory drugs (NSAIDS)

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol):

  • vomiting
  • dizziness
  • urinating less often than normal
  • headache

See “What are the possible side effects of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?” for more information about side effects.

What is Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) is a prescription medicine used to clean the colon before a colonoscopy or barium enema X-ray examination. Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy or barium enema X-ray examination.

It is not known if Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) is safe and effective in children.

Who should not take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

Do not take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) if your healthcare provider has told you that you have:

  • a blockage in your intestine (bowel obstruction)
  • an opening in the wall of your stomach or intestine (bowel perforation)
  • problems with food and fluid emptying from your stomach (gastric retention)
  • a very dilated intestine (toxic megacolon)
  • an allergy to any of the ingredients in Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). See the end of this leaflet for a complete list of ingredients in Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol).

What should I tell my healthcare provider before taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

Before you take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol), tell your healthcare provider if you:

  • have heart problems
  • have a history of seizures
  • have kidney problems
  • have ulcerative colitis
  • have stomach or bowel problems
  • have problems with swallowing or gastric reflux
  • are withdrawing from drinking alcohol
  • have a low blood salt (sodium) level
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) passes into your breast milk. You and your healthcare provider should decide if you will take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) while breastfeeding.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol).

Especially tell you healthcare provider if you take:

  • medicines for blood pressure or heart problems
  • medicines for kidney problems
  • medicines for seizures
  • water pills (diuretics)
  • non-steroidal anti-inflammatory medicines (NSAID) pain medicines
  • laxatives

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

See the Instructions for Use at the end of this Medication Guide for dosing instructions. You must read, understand, and follow these instructions to take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) the right way.

  • Take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) exactly as your healthcare provider tells you to take it.
  • The powder in the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) container must be mixed with water (diluted) before drinking. Do not take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) that has not been mixed with water, it may increase your risk of nausea, vomiting and fluid loss (dehydration).
  • Do not eat any solid foods 3 hours before you start taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol), while taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol), and 2 hours after taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol).
  • Drink clear liquids before you start taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol), while you take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) and after you finish taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) to help prevent fluid loss (dehydration). Examples of clear liquids are:
    • water
    • clear fruit juices without pulp including apple, white grape, or white cranberry
    • strained limeade or lemonade
    • coffee or tea (Do not use any dairy or non-dairy creamer)
    • clear broth
    • clear soda
    • gelatin (without added fruit or topping)
    • popsicles without pieces of fruit or fruit pulp

    Do not eat or drink anything colored red or purple.

  • Do not eat or drink anything 2 hours before your colonoscopy or barium enema X-ray examination.
  • You should have your first bowel movement about 1 hour after you start taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). Continue to take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) according to the Instructions for Use until your stool is clear, watery, and has no solid material in it.
  • Do not take other laxatives while taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol).
  • Stop drinking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution temporarily or allow for longer time between each dose if you have stomach discomfort, pain or bloating until your symptoms improve. If symptoms continue, tell your healthcare provider.

What are the possible side effects of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) can cause serious side effects, including:

  • See “What is the most important information I should know about Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?”
  • changes in certain blood tests. Your healthcare provider may do blood tests after you take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
    • vomiting
    • nausea
    • bloating
    • dizziness
    • stomach-area (abdomen) cramping
    • headache
    • urinate less than usual
    • trouble drinking clear liquid
  • ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.

The most common side effects of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) include:

  • nausea
  • stomach-area (abdomen) fullness and bloating

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). For more information, ask you healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

  • Store Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) at 68°F to 77°F (20°C to 25°C).
  • Store Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) that has been mixed with water in the refrigerator.
  • Use Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) within 48 hours after mixing with water. Safely throw away any Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) that you do not use.

Keep Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) and all medicines out of the reach of children.

General information about the safe and effective use of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) for a condition for which it was not prescribed. Do not give Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes the most important information about Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) that is written for health professionals.

For more information about Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol), call 1-888-317-0001.

What are the ingredients in Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

Active ingredients: Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) (PEG) 3350, sodium chloride, potassium chloride, sodium bicarbonate, sodium sulfate

Inactive ingredients: Flavor pack ingredients:

Orange flavor pack:hypromellose, natural and artificial orange powder, saccharin sodium, colloidal silicon dioxide

Lemon lime flavor pack: hypromellose, natural and artificial lemon lime powder, Prosweet® Powder Natural, saccharin sodium, colloidal silicon dioxide

Cherry flavor pack: hypromellose, artificial cherry powder, saccharin sodium, colloidal silicon dioxide

Issued: August/2013

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Instructions for Use

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)®(co-light) with Flavor Packs

(peg-3350 & electrolytes for oral solution)

Read this Instructions for Use before you start taking Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol). This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

How should I take Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)?

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) can be taken with or without a flavor pack. If you use a flavor pack, complete Steps 1 through 8. If you do not use a flavor pack, throw away the flavor packs and complete Steps 4 through 8.

Step 1: Remove the cap from the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle.

Step 2: Tear open 1 flavor pack of your choice and pour contents into the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle. Throw away the unused flavor packs.

Step 3: Replace the cap on the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle. Shake the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle well to mix the contents of the flavor pack into the powder.

Step 4: Remove the cap from the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle. Add water to the top of the line on the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle marked “FILL TO TOP OF LINE ONE GALLON”.

Step 5: Replace the cap on the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle tightly and shake the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle well to dissolve the powder. No other ingredients should be added to the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle.

Step 6: Refrigerate the Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution until you are ready to drink it. The Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution should be used within 48 hours after mixing.

Step 7: Drink one 8 ounce glass of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution every 10 minutes. It is best to drink each glass of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution quickly, instead of sipping it slowly. Continue drinking one 8 ounce glass of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution every 10 minutes until your stool is clear, watery, and has no solid material in it. This normally requires drinking 3 to 4 liters of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution to clean your colon. The Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) bottle should be empty or have less than 1 liter of Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution remaining when your colon cleaning is completed.

Step 8: Safely throw away any Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) solution that you do not use.

This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for:

Meda Pharmaceuticals Inc., Somerset, NJ, USA

Manufactured by: Kremers Urban Pharmaceuticals Inc., Seymour, In 47274, USA

For Medical Inquiries, Call toll-free 1-888-317-0001

Revised 08/2013

NDC 68220-133-01 Note to Pharmacist:

DISPENSE ENCLOSED MEDICATION GUIDE.

Dispense bottle and all attached flavor packs to patient.

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol)®

with

Flavor Packs

(peg-3350 & electrolytes for oral solution)

Rx Only

4011310 Rev. 08/2013 133-0310-01

Contents make 1 Gallon (3.785 Liters) of solution

This package contains the following ingredients:

Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) 3350 227.10 grams
Sodium chloride 5.53 grams
Potassium chloride 2.82 grams
Sodium bicarbonate 6.36 grams
Sodium sulfate (anhydrous) 21.50 grams

When dissolved in sufficient water to make 1 gallon, the final solution contains

125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L

sulfate, 35 mEq/L chloride and 18 mEq/L Bausch and Lomb Moisturizing All Clear (Polyethylene Glycol) 3350.

Store powder at 20° to 25°C (68° to 77°F); excursions permitted between

15° to 30°C (59° to 86°F).

KEEP RECONSTITUTED SOLUTION REFRIGERATED.

USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.

APPROXIMATE NET WEIGHT: 263 GRAMS

Filled by net weight, product may settle.

MEDA

PHARMACEUTICALS®

1 gallon (3.785 liters)

Attention Pharmacist: Dispense all

attached flavor packs to the patient.

orange

flavor pack

FOR USE ONLY IN COMBINATION WITH

THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Attention Pharmacist: Dispense all

attached flavor packs to the patient.

lemon lime

flavor pack

FOR USE ONLY IN COMBINATION WITH

THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Attention Pharmacist: Dispense all

attached flavor packs to the patient.

cherry

flavor pack

FOR USE ONLY IN COMBINATION WITH

THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Bausch and Lomb Moisturizing All Clear pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Bausch and Lomb Moisturizing All Clear available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Bausch and Lomb Moisturizing All Clear destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Bausch and Lomb Moisturizing All Clear Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Bausch and Lomb Moisturizing All Clear pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ECOLAB INC. (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."VASOCON (NAPHAZOLINE HYDROCHLORIDE) SOLUTION [CIBA VISION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "Benzalkonium". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Bausch and Lomb Moisturizing All Clear?

Depending on the reaction of the Bausch and Lomb Moisturizing All Clear after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Bausch and Lomb Moisturizing All Clear not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Bausch and Lomb Moisturizing All Clear addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Bausch and Lomb Moisturizing All Clear, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Bausch and Lomb Moisturizing All Clear consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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