Label: ADAPALENE gel
- NDC Code(s): 0363-0888-05, 0363-0888-16
- Packager: Walgreens
- This is a repackaged label.
- Source NDC Code(s): 68462-403
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
-
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
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 become 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 result
- avoid product contact eyes, lips, and month. If contact occurs immediately flush the area with water.
- wash hands after use
Stop use and ask a doctor if
- you become pregnant, or planning to become pregnant while using this product
- you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
- irritation become severe
- you see no improvement after 3 months of once daily use
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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 in 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
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to the active ingredient in Differin® Gel††
0.1%
Adapalene Treatment Gel
ADAPALENE USP 0.1% (RETINOID) /
ACNE TREATMENT
Oil
Fragrance Free
- Previously available only by prescription
- Dermatologist developed & FDA approved
- Once daily topical retinoid*
NET WT OZ (g)
*READ CONSUMER INFORMATION LEAFLET BEFORE USE.
First FDA-Approved over-the-counter topical retinoid* for acne treatment
*Read carton and enclosed consumer information leaflet before using this product. Keep this carton and consumer information leaflet. They contain important information.
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
††This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.
DISTRIBUTED BY WALGREEN CO.
200 WILMOT ROAD
DEERFIELD, IL 60015
- Product Label
-
INGREDIENTS AND APPEARANCE
ADAPALENE
adapalene gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0888(NDC:68462-403) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) POLOXAMER 182 (UNII: JX0HIX6OAG) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0888-05 1 in 1 CARTON 04/30/2021 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0363-0888-16 1 in 1 CARTON 04/30/2021 2 45 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091314 04/30/2021 Labeler - Walgreens (008965063)
