adapalene

FDA Drug Profile — Adapalene, adapalene, DIFFERIN

Drug Details

Generic Name
adapalene
Brand Names
Adapalene, adapalene, DIFFERIN
Application Number
ANDA090824
Sponsor
Bryant Ranch Prepack
NDC Codes
5
Dosage Forms
CREAM, GEL
Routes
TOPICAL
Active Ingredients
ADAPALENE

Indications and Usage

Use For the treatment of acne

Warnings

Warnings For external use only Do not use on damaged skin (cuts, abrasions, eczema, sunburn) if you are allergic to adapalene or any of the ingredients in this product. If pregnant or breast-feeding, ask a doctor before use. When using this product limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors do not wax to remove hair in areas where the product has been applied during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe irritation (redness, itching, dryness, burning) is more likely to occur: in the first few weeks of use if using more than one topical acne medication at a time but irritation usually lessens with continued use of this product it may take up to 3 months of once daily use to see results avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water. wash hands after use Stop use and ask doctor if you become pregnant, or are planning to become pregnant, while using the product you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) irritation becomes severe you see no improvement after 3 months of once daily use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.