"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
FABIOR® (tazarotene) Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.
DOSAGE AND ADMINISTRATION
FABIOR Foam is for topical use only. FABIOR Foam is not for oral, ophthalmic, or intravaginal use.
FABIOR Foam should be applied once daily in the evening after washing with a mild cleanser and fully drying the affected area. Dispense a small amount of foam into the palm of the hand. Using fingertips, apply only enough foam to lightly cover the entire affected areas of the face and/or upper trunk with a thin layer; gently massage the foam into the skin until the foam disappears. Avoid the eyes, lips, and mucous membranes. Wash hands after application.
Patients may use moisturizer as needed.
If undue irritation (redness, peeling, or discomfort) occurs, patients should reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides. Treatment should be discontinued if irritation persists.
Dosage Forms And Strengths
0.1%, white to off-white foam
FABIOR Foam, 0.1% (1 mg/g) is a white to off-white foam, supplied as follows:
50-g aluminum can NDC
100-g aluminum can NDC 0145-0020-02
Storage And Handling
- Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.
- Store upright.
- Protect from freezing.
- Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).
- Shake can before use. Hold can at an upright angle and press firmly to dispense.
Manufactured for: Stiefel Laboratories, Inc., Research Triangle Park, NC 27709. Revised: Dec 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/12/2016
Additional Fabior Information
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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