Effaclar
Effaclar is an FDA drug label for the active ingredient ADAPALENE manufactured by LOreal USA Products Inc administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20190823.
Generic: ADAPALENE
Manufacturer: LOreal USA Products Inc
Product Type: HUMAN OTC DRUG
Route: TOPICAL
Dosage Form:
NDC: 49967-591
Application: ANDA091314
Effective: 20190823
Active Ingredients: Active ingredient Adapalene USP 0.1% (retinoid)* *read consumer information leaflet
Indications & Usage
Use • for the treatment of acne
Dosage & Administration
Directions Adults and children 12 years of age and older: • use once daily • clean the skin gently and pat dry before applying the product • cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face. • do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation. Children under 12 years of age : ask a doctor
Contraindications
Not available.
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
Adverse Reactions
Not available.