Atralin
INDICATIONS
Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris.
Important Limitations of Use
The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated.
DOSAGE AND ADMINISTRATION
Atralin Gel should be applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area. Atralin Gel should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Application of excessive amounts of gel will not provide incremental efficacy.
Patients treated with Atralin Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.
Dosage Forms And Strengths
0.05% weight/weight topical gel, in 45 gram tubes
HOW SUPPLIED
HOW SUPPLIED/STORAGE AND HANDLING
Atralin (tretinoin) Gel, 0.05% is available as:
- 45 g tubes (NDC 13548-070-45)
Storage and Handling
Store at controlled room temperature 20° - 25°C (68° - 77°F) with excursions permitted between 15°-30°C (59°-86°F). Protect from freezing. Keep out of reach of children.
Marketed by: CORIA LABORATORIES, LTD., Fort Worth, TX 76107
Manufactured by: DPT LABORATORIES, LTD., San Antonio, TX 78215
FDA rev date: 7/26/2007
Generic Name: Tretinoin
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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Atralin
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