Label: ADAPALENE gel
- NDC Code(s): 59726-888-05
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 7, 2021
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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
†Compare to the active ingredient in Differin® Gel
adapalene gel USP, 0.1%
- Previously available only by prescription
- Dermatologist developed
- Once daily topical retinoid*
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.
200 Hicks Street
Westbury, NY 11590
- Product Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-888 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:59726-888-05 1 in 1 CARTON 05/28/2021 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 05/28/2021 Labeler - P & L Development, LLC (800014821)