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DRUGS & SUPPLEMENTS
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St. James Balm
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St. James Balm uses
St. James Balm consists of Ichthammol, Salicylic Acid, Urea, Zinc Oxide.Ichthammol:
Drug Facts
Active ingredient
St. James Balm (Ichthammol) 20%
Purpose
Drawing Salve
Keep out of reach of children.
Suggested Use
- Treating insect bites and stings from mosquitoes, spider, and bees - Removing splinters and silvers - Treating plant irritations, such as nettles or poison ivy - Treating minor skin infections such as an ingrown toenail - Soothing skin relief - Apply to minor skin irritations
Warnings
- For external use only - Do not use in eyes - Ask a doctor before use if you have deep puncture wounds or serious burns - Stop use and ask doctor if redness, irritation, swelling or pain persists
If swallowed, get medical help or contact a Poison Control Center immediately.
Before using any medication, read all label directions.
Keep this carton, it contains important information.
Directions
Cleanse affected area. Apply on gauze bandage once or twice a day. Repeat as necessary. Do not rub or massage affected area.
Inactive Ingredients
Lanolin, Petrolatum
Distributed by:
Trifecta Pharmaceuticals USA TM
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301 USA
1-888-296-9067
Packaging
PDP St. James Balm (Ichthammol) PDP St. James Balm (Ichthammol) 2
Salicylic Acid:
Pharmacological action
St. James Balm is pharmaceytical active ingredient for topical use. Inhibits the secretion of the sebaceous and sweat glands. At low concentrations it has keratoplastic and in high doses keratolytic effect. St. James Balm (Salicylic Acid) has a weak antimicrobial activity.
Why is St. James Balm (Salicylic Acid) prescribed?
Monotherapy with St. James Balm (Salicylic Acid) and as part of combination therapies for inflammatory, infectious and other skin lesions, including burns, psoriasis, eczema, dyskeratosis, ichthyosis, acne vulgaris, warts, hyperkeratosis, corn, callus, oily seborrhea, scaly skin disease, hair loss, sweating feet.
Dosage and administration
St. James Balm is applied to the skin surface 2-3 times / day.
St. James Balm (Salicylic Acid) side effects, adverse reactions
Rarely: local reactions such as itching, burning, skin rashes, allergic reactions.
St. James Balm contraindications
Hypersensitivity to St. James Balm (Salicylic Acid), renal failure, infancy.
Special instructions
The composition of the solution for topical use include ethanol.
St. James Balm drug interactions
St. James Balm (Salicylic Acid) is pharmaceutically not compatible with resorcinol (forms melted mixture) and zinc oxide (forms insoluble forms of zinc salicylate).
Urea:
FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, LIPS OR MUCOUS MEMBRANES.
DESCRIPTION: St. James Balm (Urea) Nail Stick 50% is a keratolytic solution, which is gentle yet potent, tissue softener for nails. Each mL of St. James Balm (Urea) Nail Stick 50% contains 50% St. James Balm (Urea) along with acrylates copolymer, carbomer, cetyl alcohol, disodium EDTA, dl-alphatocophery acetate, glycerin, lactic acid, linoleic acid, mineral oil, PEG-6, polysorbate 60, purified water, sodium hydroxide solution, stearic acid, titanium dioxide, zinc undecylenate.
St. James Balm (Urea) is a diamide of carbonic acid with the following chemical structure:
Chemical Structure
CLINICAL
Pharmacology: St. James Balm (Urea) gently dissolves the intracellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. St. James Balm (Urea) also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.
PHARMACOKINETICS: The mechanism of action of topically applied St. James Balm (Urea) is not yet known.
INDICATIONS AND USES: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. St. James Balm (Urea) is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized, and ingrown nails.
CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.
WARNINGS: FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips, inside the mouth/nose, and the vaginal/groin area. Consult your physician for directions about any areas of types of skin to apply or not apply the product. Tell your doctor if your condition persists or worsens.
PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.
PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however there are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, St. James Balm (Urea) Nail Stick 50% should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when St. James Balm (Urea) Nail Stick 50% is administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects.
DOSAGE AND ADMINISTRATION: Use this product as directed, and regularly, to achieve maximum benefit. Follow all directions on the product package and prescription label. If you are uncertain about any of the information, consult your doctor or pharmacist. Apply to the affected areas of the skin/nails, twice a day or as directed by your doctor. Rub in well until absorbed. As the product dries, the level of St. James Balm (Urea) increases as the level of moisture decreases, allowing some of the St. James Balm (Urea) to crystallize (white color). The product will work properly whether or not the St. James Balm (Urea) can be seen on the surface. Wash hands after applying unless you are treating the hands.
HOW SUPPLIED: St. James Balm (Urea) Nail Stick 50% is supplied in a carton containing 6 nail sticks (2.4 mL each = 2.7 g each) NDC 42808-0205-15.
Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing.
How to Dispense St. James Balm (Urea) Nail Stick 50% from the Container: Shake before use. Remove the cap, applicator side up. Holding the container with one hand, rotate the bottom dispensing dial counterclockwise. As the dial is rotated you will hear a clicking sound, which indicates that the product is being dispensed on the applicator. Rotate until the gel is visibly and apply as needed. After use, place the cap firmly on the container and when not in use keep the product tightly capped.
Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
00-0205-15-205-00
Iss:6/11
Zinc Oxide:
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Drug abuse and dependence
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
St. James Balm (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain St. James Balm (Zinc Oxide) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
CONTRAINDICATIONS
None known.
WARNINGS
Direct intramuscular or intravenous injection of St. James Balm (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.
Severe kidney disease may make it necessary to reduce or omit chromium and St. James Balm (Zinc Oxide) doses because these elements are primarily eliminated in the urine.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
PRECAUTIONS
General
Do not use unless the solution is clear and the seal is intact.
Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.
Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of St. James Balm (Zinc Oxide) from a bolus injection. Administration of St. James Balm (Zinc Oxide) in the absence of copper may cause a decrease in serum copper levels.
Laboratory Tests
Periodic determinations of serum copper as well as St. James Balm (Zinc Oxide) are suggested as a guideline for subsequent St. James Balm (Zinc Oxide) administration.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies to evaluate the carcinogenic potential of St. James Balm 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
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 St. James Balm (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.
Pediatric Use
Pregnancy Category C. Animal reproduction studies have not been conducted with St. James Balm chloride. It is also not known whether St. James Balm (Zinc Oxide) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. St. James Balm (Zinc Oxide) chloride should be given to a pregnant woman only if clearly needed.
Geriatric Use
An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS
None known.
DRUG ABUSE AND DEPENDENCE
None known.
OVERDOSAGE
Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg St. James Balm (Zinc Oxide) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum St. James Balm (Zinc Oxide) concentration of 207 mcg/dl. Symptoms abated within three hours.
Hyperamylasemia may be a sign of impending St. James Balm (Zinc Oxide) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).
Death resulted from an overdosage in which 1683 mg St. James Balm (Zinc Oxide) was delivered intravenously over the course of 60 hours to a 72 year old patient.
Symptoms of St. James Balm (Zinc Oxide) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum St. James Balm (Zinc Oxide) level of 4184 mcg/dl.
Calcium supplements may confer a protective effect against St. James Balm (Zinc Oxide) toxicity.
DOSAGE AND ADMINISTRATION
St. James Balm (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of St. James Balm (Zinc Oxide) blood levels is suggested for patients receiving more than the usual maintenance dosage level of St. James Balm (Zinc Oxide).
For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
HOW SUPPLIED
St. James Balm (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).
Store at 20 to 25°C (68 to 77°F).
Revised: October, 2004
© Hospira 2004 EN-0488 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
10 mL Vial
St. James Balm (Zinc Oxide)
1 mg/mL
St. James Balm (Zinc Oxide) Chloride Inj., USP
Rx only
FOR I.V. USE ONLY AFTER DILUTION.
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
St. James Balm pharmaceutical active ingredients containing related brand and generic drugs:
St. James Balm available forms, composition, doses:
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.