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DRUGS & SUPPLEMENTS
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Dristan 12-hr Nasal Decongestant Spray cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
Dristan 12-hr Nasal Decongestant Spray is an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. (1)
For topical use only. Dristan 12-hr Nasal Decongestant Spray is not for oral, ophthalmic, or intravaginal use.
Prime the Dristan 12-hr Nasal Decongestant Spray pump before using for the first time. To do so, with the pump in the upright position, repeatedly depress the actuator until cream is dispensed and then pump three times. Discard the cream from priming actuations. It is only necessary to prime the pump before the first dose.
Dristan 12-hr Nasal Decongestant Spray tubes do not require priming.
Apply a pea-sized amount of Dristan 12-hr Nasal Decongestant Spray cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. Wash hands immediately after applying Dristan 12-hr Nasal Decongestant Spray cream.
Dristan 12-hr Nasal Decongestant Spray (oxymetazoline hydrochloride) cream, 1% is a white to off-white cream. Each gram of cream contains 10 mg (1%) Dristan 12-hr Nasal Decongestant Spray, equivalent to 8.8 mg (0.88%) of oxymetazoline free base.
Cream, 1%. Each gram of cream contains 10 mg (1%) Dristan 12-hr Nasal Decongestant Spray, equivalent to 8.8 mg (0.88%) of oxymetazoline free base. (3)
None.
Alpha-adrenergic agonists may impact blood pressure. Dristan 12-hr Nasal Decongestant Spray should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and uncontrolled hypertension or hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.
Dristan 12-hr Nasal Decongestant Spray should be used with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.
Dristan 12-hr Nasal Decongestant Spray may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
Most common adverse reactions are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 489 subjects with persistent facial erythema associated with rosacea were treated with Dristan 12-hr Nasal Decongestant Spray once daily for 4 weeks in 3 controlled clinical trials. An additional 440 subjects with persistent facial erythema associated with rosacea were also treated with Dristan 12-hr Nasal Decongestant Spray once daily for up to one year in a long-term (open-label) clinical trial. Adverse reactions that occurred in at least 1% of subjects treated with Dristan 12-hr Nasal Decongestant Spray through 4 weeks of treatment are presented in Table 1 below.
Adverse Reaction | Pooled Controlled Clinical Trials | |
Dristan 12-hr Nasal Decongestant Spray Cream (N = 489) | Vehicle Cream (N = 483) | |
Application site dermatitis | 9 (2%) | 0 |
Worsening inflammatory lesions of rosacea | 7 (1%) | 1 (<1%) |
Application site pruritus | 5 (1%) | 4 (1%) |
Application site erythema | 5 (1%) | 2 (<1%) |
Application site pain | 4 (1%) | 1 (<1%) |
In the long-term (open-label) clinical trial, the rates of adverse reactions over a one-year treatment period were as follows: worsening inflammatory lesions of rosacea (3%), application site dermatitis (3%), application site pruritis (2%), application site pain (2%), and application site erythema (2%). Subjects with persistent erythema along with inflammatory lesions were allowed to use additional therapy for the inflammatory lesions of rosacea.
Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised.
Caution should also be exercised in patients receiving alpha1 adrenergic receptor antagonists such as in the treatment of cardiovascular disease, benign prostatic hypertrophy, or Raynaud's disease.
Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Risk Summary
There are no available data on Dristan 12-hr Nasal Decongestant Spray use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. A literature article describing intranasal decongestant use in pregnant women identified a potential association between second-trimester exposure to oxymetazoline and renal collecting system anomalies . In animal reproduction studies, there were no adverse developmental effects observed after oral administration of Dristan 12-hr Nasal Decongestant Spray in pregnant rats and rabbits at systemic exposures up to 3 times and 73 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Following repeated use of Dristan 12-hr Nasal Decongestant Spray solution nasal spray for the treatment of nasal congestion at a dose 5 times higher than recommended, one case of fetal distress was reported in a 41-week pregnant patient. The fetal distress resolved hours later, prior to the delivery of the healthy infant. The anticipated exposures for the case are 8- to18-fold higher than plasma exposures after topical administration of Dristan 12-hr Nasal Decongestant Spray.
Data
Human Data
No adequate and well-controlled trials of Dristan 12-hr Nasal Decongestant Spray have been conducted in pregnant women. Across all clinical trials of Dristan 12-hr Nasal Decongestant Spray, two pregnancies were reported. One pregnancy resulted in the delivery of a healthy child. One pregnancy resulted in a spontaneous abortion, which was considered to be unrelated to the trial medication. A literature article summarizing the results of exploratory analyses of intranasal decongestant use during pregnancy identified a potential association between second-trimester exposure to Dristan 12-hr Nasal Decongestant Spray solution (with no decongestant exposure in the first trimester) and renal collecting system anomalies.
Animal Data
Effects on embryo-fetal development were evaluated in rats and rabbits following oral administration of Dristan 12-hr Nasal Decongestant Spray during the period of organogenesis. Dristan 12-hr Nasal Decongestant Spray did not cause adverse effects to the fetus at oral doses up to 0.2 mg/kg/day in pregnant rats during the period of organogeneisis (3 times the MRHD on an AUC comparison basis). Dristan 12-hr Nasal Decongestant Spray did not cause adverse effects to the fetus at oral doses up to 1 mg/kg/day in pregnant rabbits during the period of organogeneisis (73 times the MRHD on an AUC comparison basis). Maternal toxicity, such as decreased maternal body weight, was produced at the high dose of 1 mg/kg/day in pregnant rabbits and was associated with findings of delayed skeletal ossification.
In a rat perinatal and postnatal development study, Dristan 12-hr Nasal Decongestant Spray was orally administered to pregnant rats once daily from gestation day 6 through lactation day 20. Maternal toxicity was produced at the high dose of 0.2 mg/kg/day (3 times the MRHD on an AUC comparison basis) in pregnant rats and was associated with an increase in pup mortality and reduced pup body weights. Delayed sexual maturation was noted at 0.1 and 0.2 mg/kg/day (2 times the MRHD and 3 times the MRHD on an AUC comparison basis, respectively). Dristan 12-hr Nasal Decongestant Spray did not have any adverse effects on fetal development at a dose of 0.05 mg/kg/day (one-half of the MRHD on an AUC comparison basis).
No clinical data are available to assess the effects of oxymetazoline on the quantity or rate of breastmilk production, or to establish the level of oxymetazoline present in human breastmilk post-dose. Oxymetazoline was detected in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dristan 12-hr Nasal Decongestant Spray and any potential adverse effects on the breastfed child from Dristan 12-hr Nasal Decongestant Spray or from the underlying maternal condition.
Safety and effectiveness of Dristan 12-hr Nasal Decongestant Spray have not been established in pediatric patients below the age of 18 years.
One hundred and ninety-three subjects aged 65 years and older received treatment with Dristan 12-hr Nasal Decongestant Spray (n = 135) or vehicle (n = 58) in clinical trials. No overall differences in safety or effectiveness were observed between subjects≥ 65 years of age and younger subjects, based on available data. Clinical studies of Dristan 12-hr Nasal Decongestant Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Dristan 12-hr Nasal Decongestant Spray is not for oral use. If oral ingestion occurs, seek medical advice. Monitor patient closely and administer appropriate supportive measures as necessary. Accidental ingestion of topical solutions (nasal sprays) containing imidazoline derivatives (e.g., oxymetazoline) in children has resulted in serious adverse events requiring hospitalization, including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma. Keep Dristan 12-hr Nasal Decongestant Spray out of reach of children.
Dristan 12-hr Nasal Decongestant Spray (oxymetazoline hydrochloride) cream 1% contains Dristan 12-hr Nasal Decongestant Spray, an alpha1A adrenoceptor agonist. Dristan 12-hr Nasal Decongestant Spray is a white to off-white cream. It has a chemical name of 3-[(4,5-Dihydro-1H-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethyl-phenol hydrochloride and a molecular weight of 296.8. It is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water. The molecular formula of oxymetazoline HCl is C16H25ClN2O and its structural formula is:
Each gram of Dristan 12-hr Nasal Decongestant Spray (oxymetazoline hydrochloride) cream contains 10 mg (1%) Dristan 12-hr Nasal Decongestant Spray, equivalent to 8.8 mg (0.88%) of oxymetazoline free base. The cream contains the following inactive ingredients: sodium citrate dihydrate, citric acid anhydrous, disodium edetate dihydrate, butylated hydroxytoluene, anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, oleyl alcohol, polyethylene glycol 300, PEG-6 stearate, glycol stearate, PEG-32 stearate, cetostearyl alcohol, ceteareth-6, stearyl alcohol, ceteareth-25, methylparaben, propylparaben, phenoxyethanol, and purified water.
Oxymetazoline is an alpha1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor.
The pharmacodynamics of Dristan 12-hr Nasal Decongestant Spray has not been studied.
Absorption
The pharmacokinetics of oxymetazoline was evaluated following topical administration of Dristan 12-hr Nasal Decongestant Spray in a thin layer to cover the entire face in adult subjects with erythema associated with rosacea. The median weight of cream for each dose administration was 0.3 g. Plasma oxymetazoline concentrations were measurable in most of the subjects. Following the first dose application, the mean ± standard deviation (SD) peak concentrations (Cmax) and area under the concentration-time curves from time 0 to 24 hours (AUC0-24hr) were 60.5 ± 53.9 pg/mL and 895 ±798 pg*hr/mL, respectively. Following once daily applications for 28 days, the mean ± SD Cmax and AUC0-24hr were 66.4 ± 67.1 pg/mL and 1050 ± 992 pg*hr/mL, respectively. Following twice daily applications (twice the recommended frequency of application) for 28 days, the mean ± SD Cmax and AUC0-24hr were 68.8 ± 61.1 pg/mL and 1530 ± 922 pg*hr/mL, respectively.
Distribution
An in vitro study demonstrated that oxymetazoline is 56.7% to 57.5% bound to human plasma proteins.
Metabolism
In vitro studies using human liver microsomes showed that oxymetazoline was minimally metabolized, generating mono-oxygenated and dehydrogenated products of oxymetazoline. The percentage of parent drug oxymetazoline remaining was 95.9% after a 120-minute incubation with human liver microsomes.
Excretion
The excretion of oxymetazoline following administration of Dristan 12-hr Nasal Decongestant Spray has not been characterized in humans.
Drug Interaction
In vitro studies using human liver microsomes demonstrated that oxymetazoline up to the tested concentration of 100 nM had no inhibition on the activities of the cytochrome P450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5. Treatment of cultured human hepatocytes with up to 100 nM oxymetazoline did not induce CYP1A2, CYP2B6, or CYP3A4.
Dristan 12-hr Nasal Decongestant Spray was not associated with an increased incidence of neoplastic or proliferative changes in transgenic mice given oral doses of 0.5, 1.0, or 2.5 mg/kg/day Dristan 12-hr Nasal Decongestant Spray for 6 months.
Dristan 12-hr Nasal Decongestant Spray revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and human lymphocyte chromosomal aberration assay) and one in vivo gentoxicity test (mouse micronucleus assay).
Effects on fertility and early embryonic development were evaluated in rats following oral administration of 0.05, 0.1, or 0.2 mg/kg/day Dristan 12-hr Nasal Decongestant Spray prior to and during mating and through early pregnancy. Decreased number of corpora lutea and increased post-implantation losses were noted at 0.2 mg/kg/day Dristan 12-hr Nasal Decongestant Spray (3 times the MRHD on an AUC comparison basis). However, no treatment related effects on fertility or mating parameters were noted at 0.2 mg/kg/day Dristan 12-hr Nasal Decongestant Spray (3 times the MRHD on an AUC comparison basis).
Dristan 12-hr Nasal Decongestant Spray was evaluated for the treatment of persistent erythema associated with rosacea in two identical, randomized, double-blind, vehicle-controlled, parallel-group clinical trials. The trials enrolled 885 subjects aged 18 years and older. Overall, 90% of subjects were Caucasian and 79% were female. Subjects applied either Dristan 12-hr Nasal Decongestant Spray or vehicle once daily for 29 days.
Disease severity was graded by the clinician using a 5-point clinician erythema assessment (CEA) scale and by the subject on a similar 5-point subject self-assessment (SSA) scale, on which subjects scored either “moderate” or “severe” on both scales.
CEA and SSA were measured over a 12-hour period at equally-spaced timepoints (hours 3, 6, 9, and 12) post-dose on Days 1, 15, and 29. The primary efficacy endpoint was defined as the proportion of subjects with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on Day 1) on both the CEA and SSA measured at hours 3, 6, 9, and 12 on Day 29. The results from both trials on the composite endpoint for Day 29 are presented in Table 2.
Time-point (Hour) | Trial 1 | Trial 2 | ||
Dristan 12-hr Nasal Decongestant Spray Cream | Vehicle Cream | Dristan 12-hr Nasal Decongestant Spray Cream | Vehicle Cream | |
(N=222) | (N=218) | (N = 224) | (N=221) | |
3 | 12% | 6% | 14% | 7% |
6 | 16% | 8% | 13% | 5% |
9 | 18% | 6% | 16% | 9% |
12 | 15% | 6% | 12% | 6% |
*Composite success is defined as the proportion of subjects achieving at least a 2-grade improvement on both CEA and SSA.
Dristan 12-hr Nasal Decongestant Spray (oxymetazoline hydrochloride) cream, 1%, is a white to off-white cream. The product is available in a laminated tube and an airless pump polypropylene bottle in the following packaging configurations, each with a child-resistant closure:
NDC 0023-5300-30 30 gram tube
NDC 0023-5300-60 60 gram tube
NDC 0023-5300-35 30 gram pump
NDC 0023-5300-65 60 gram pump
Storage: Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30ºC (59°F-86ºF).
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Important Administration Instructions
Advise patients of the following:
Manufactured for Allergan, Irvine, CA 92612, U.S.A.
by DPT Laboratories, Ltd, San Antonio, TX 78215
© 2017 Allergan. All rights reserved.
Irvine, CA 92612
All trademarks are the property of their respective owners.
Patented. See www.allergan.com/patents
Made in the U.S.A.
73141US10
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This Patient Information has been approved by the U.S. Food and Drug Administration | Approved: 01/2017 | ||
PATIENT INFORMATION Dristan 12-hr Nasal Decongestant Spray (roe' fayd) (oxymetazoline hydrochloride) cream | |||
Important: Dristan 12-hr Nasal Decongestant Spray cream is for skin (topical) use on the face only. Do not use Dristan 12-hr Nasal Decongestant Spray cream in your eyes, mouth, or vagina. Keep Dristan 12-hr Nasal Decongestant Spray cream out of the reach of children. Get medical help right away if you, a child, or anyone else swallows Dristan 12-hr Nasal Decongestant Spray cream. | |||
What is Dristan 12-hr Nasal Decongestant Spray cream? Dristan 12-hr Nasal Decongestant Spray cream is a prescription medicine used on the skin (topical) to treat facial redness due to rosacea that does not go away (persistent) in adults. It is not known if Dristan 12-hr Nasal Decongestant Spray cream is safe and effective in children under 18 years of age. | |||
Before you use Dristan 12-hr Nasal Decongestant Spray cream, tell your healthcare provider about all of your medical conditions, including if you:
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, skin products, vitamins, and herbal supplements. Using Dristan 12-hr Nasal Decongestant Spray cream with certain other medicines may affect each other and can cause serious side effects. | |||
How should I use Dristan 12-hr Nasal Decongestant Spray cream? See the detailed Instructions for Use that comes with your Dristan 12-hr Nasal Decongestant Spray cream tube or pump for information about how to apply Dristan 12-hr Nasal Decongestant Spray cream correctly. Use Dristan 12-hr Nasal Decongestant Spray cream exactly as your healthcare provider tells you. Do not use more Dristan 12-hr Nasal Decongestant Spray cream than prescribed. Dristan 12-hr Nasal Decongestant Spray cream is for use on your skin only. Do not use Dristan 12-hr Nasal Decongestant Spray cream in your eyes, mouth, or vagina. Avoid contact with your lips and eyes. Do not apply Dristan 12-hr Nasal Decongestant Spray cream to irritated skin or open wounds. | |||
What are the possible side effects of Dristan 12-hr Nasal Decongestant Spray cream? The most common side effects of Dristan 12-hr Nasal Decongestant Spray cream include application site reactions of: | |||
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These are not all the possible side effects of Dristan 12-hr Nasal Decongestant Spray cream. 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 Dristan 12-hr Nasal Decongestant Spray cream?
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Keep Dristan 12-hr Nasal Decongestant Spray cream and all medicines out of the reach of children. | |||
General information about the safe and effective use of Dristan 12-hr Nasal Decongestant Spray cream Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Dristan 12-hr Nasal Decongestant Spray cream for a condition for which it was not prescribed. Do not give Dristan 12-hr Nasal Decongestant Spray cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Dristan 12-hr Nasal Decongestant Spray cream that is written for health professionals. | |||
What are the ingredients in Dristan 12-hr Nasal Decongestant Spray cream? Active ingredient: Dristan 12-hr Nasal Decongestant Spray Inactive ingredients: sodium citrate dihydrate, citric acid anhydrous, disodium edetate dihydrate, butylated hydroxytoluene, anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, oleyl alcohol, polyethylene glycol 300, PEG-6 stearate, glycol stearate, PEG-32 stearate, cetostearyl alcohol, ceteareth-6, stearyl alcohol, ceteareth-25, methylparaben, propylparaben, phenoxyethanol, and purified water | |||
Manufactured for Allergan, Irvine, CA 92612, U.S.A. by DPT Laboratories, Ltd, San Antonio, TX 78215 © 2017 Allergan. All rights reserved. Irvine, CA 92612, U.S.A. All trademarks are the property of their respective owners. Patented. See www.allergan.com/patents. Made in the U.S.A. | |
73141US10
INSTRUCTIONS FOR USE
Dristan 12-hr Nasal Decongestant Spray (roe' fayd)
(oxymetazoline hydrochloride)
cream
Tube
Important:
|
Read and follow the steps below so that you use your tube of Dristan 12-hr Nasal Decongestant Spray cream correctly:
Step 1: Open the tube of Dristan 12-hr Nasal Decongestant Spray cream by gently pressing down on the child-resistant cap and twisting it counterclockwise until the cap is removed. Do not squeeze the tube while opening or closing. Note: When the cap is removed, the tube is not child-resistant. | |
Step 2: To apply Dristan 12-hr Nasal Decongestant Spray cream to your face, squeeze a pea-sized amount of Dristan 12-hr Nasal Decongestant Spray cream from the tube onto your fingertip. | |
Step 3: Apply the pea-sized amount of Dristan 12-hr Nasal Decongestant Spray cream to cover your entire face (forehead, nose, each cheek, and chin) 1 time each day. Spread the cream smoothly and evenly in a thin layer over your face.
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Step 4: To close your Dristan 12-hr Nasal Decongestant Spray cream tube, place the cap back on the tube. Press down on the child-resistant cap and twist clockwise until it stops. The tube is child-resistant again. | |
Step 5: Wash your hands right away after applying Dristan 12-hr Nasal Decongestant Spray cream. |
How do I store Dristan 12-hr Nasal Decongestant Spray cream?
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Keep Dristan 12-hr Nasal Decongestant Spray cream and all medicines out of the reach of children. |
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for Allergan, Irvine, CA 92612, U.S.A.
by DPT Laboratories, Ltd, San Antonio, TX 78215
© 2017 Allergan. All rights reserved. Irvine, CA 92612, U.S.A.
All trademarks are the property of their respective owners.
Patented. See www.allergan.com/patents. Made in the U.S.A.
Approved: 01/2017
73141US10
Figure Figure Figure Figure
INSTRUCTIONS FOR USE
Dristan 12-hr Nasal Decongestant Spray (roe' fayd)
(oxymetazoline hydrochloride) cream
Pump
Important:
|
Read and follow the steps below so that you use your Dristan 12-hr Nasal Decongestant Spray cream pump correctly:
Step 1: Open the Dristan 12-hr Nasal Decongestant Spray cream pump by pushing down on the child-resistant cap and twisting it counterclockwise until the cap is removed. The clear sticker will break when opening for the first time. Note: When the cap is removed, the pump is not child-resistant. | ||
Prime your Dristan 12-hr Nasal Decongestant Spray cream pump before the first use only. Hold the pump upright and press down several times until the cream is dispensed onto a tissue. Pump 3 more times onto the tissue and throw away (discard) the tissue. Your pump is now ready to use. | | |
Step 2: To apply Dristan 12-hr Nasal Decongestant Spray cream to your face, press down on the pump one time to dispense a pea-sized amount of Dristan 12-hr Nasal Decongestant Spray cream onto your fingertip. | | |
Step 3: Apply the pea-sized amount of Dristan 12-hr Nasal Decongestant Spray cream to cover your entire face (forehead, nose, each cheek, and chin) 1 time each day. Spread the cream smoothly and evenly in a thin layer over your face.
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Step 4: To close your Dristan 12-hr Nasal Decongestant Spray cream pump, place the cap back on the pump. Push down on the child-resistant cap and turn the cap clockwise until it stops. The pump is child-resistant again. | | |
Step 5: Wash your hands right away after applying Dristan 12-hr Nasal Decongestant Spray cream. |
How do I store Dristan 12-hr Nasal Decongestant Spray cream?
| |
Keep Dristan 12-hr Nasal Decongestant Spray cream and all medicines out of the reach of children. |
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for Allergan, Irvine, CA 92612, U.S.A.
by DPT Laboratories, Ltd, San Antonio, TX 78215
© 2017 Allergan. All rights reserved. Irvine, CA 92612, U.S.A.
All trademarks are the property of their respective owners.
Patented. See www.allergan.com/patents. Made in the U.S.A.
Approved: 01/2017
73141US10
Figure Figure Figure Figure Figure
NDC 0023-5300-30
Dristan 12-hr Nasal Decongestant Spray
(oxymetazoline hydrochloride) cream, 1%*
*Each gram of Dristan 12-hr Nasal Decongestant Spray cream contains 10 mg
of Dristan 12-hr Nasal Decongestant Spray, equivalent to
8.8 mg of oxymetazoline free base
For Topical Use Only
Keep Out of Reach of Children
Allergan
Rx only
30 g
Principal Display Panel
Depending on the reaction of the Dristan 12-hr Nasal Decongestant Spray after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dristan 12-hr Nasal Decongestant Spray 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 Dristan 12-hr Nasal Decongestant Spray 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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The information was verified by Dr. Rachana Salvi, MD Pharmacology