Label: ADAPALENE GEL 0.1% gel
- NDC Code(s): 73715-003-01
- Packager: MOHNARK PHARMACEUTICALS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated September 19, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
- WARNINGS
- USES
- DO NOT 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 irritation that becomes severe
- irritation (redness, itching, dryness, burning) is more likely to occur
- in the first few weeks of use
- if using more 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 area with water
- wash hands after use
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
Adults and children 2 years 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 results or better results, but may worsen skin irritation.
Children under 12 years of age ask a doctor
- OTHER INFORMATION
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ADAPALENE GEL 0.1%
adapalene gel 0.1% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73715-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER 980 (UNII: 4Q93RCW27E) BENZYL ALCOHOL (UNII: LKG8494WBH) POLOXAMER 124 (UNII: 1S66E28KXA) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73715-003-01 30 g in 1 TUBE; Type 0: Not a Combination Product 09/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/30/2024 Labeler - MOHNARK PHARMACEUTICALS INC (117013830)