FDA Label for Adapalene Gel
View Indications, Usage & Precautions
Adapalene Gel Product Label
The following document was submitted to the FDA by the labeler of this product Acne Free Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Adapalene USP 0.1% (retinoid)*
*read consumer information leaflet
Purpose
.Acne treatment
Use
for the treatment of acne
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
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 A 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 right away
Directions
• 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. Adults and children 12 years of age and older:
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
Other Information
store at room temperature 68° to 77°F protect from freezing
Inactive Ingredient
carbomer homopolymer, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water and sodium hydroxide
Questions Or Comments
1-800-768-2913
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