Label: ADAPALENE gel
- NDC Code(s): 36800-088-05
- Packager: TOP CARE (Topco Associates LLC)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 28, 2020
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- Active ingredient
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
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
ADAPALENE GEL USP, 0.1%
Compare to Differin® GEL active ingredient*
- Previously available only by prescription
- Dermatologist developed
- Once daily topical retinoid*
Oil free & Fragrance free
Dermatologist developed and tested
*Read consumer information leaflet before use
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 TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
- Product Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-088 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:36800-088-05 1 in 1 CARTON 07/30/2020 1 15 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 07/30/2020 Labeler - TOP CARE (Topco Associates LLC) (006935977)