Label: ADAPALENE gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 5, 2020

If you are a consumer or patient please visit this version.

  • 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

    Pregnancy/Breastfeeding,

    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 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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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

    • store at rooms temperature 68º to 77ºF
    • protect from freezing
  • Inactive ingredients

    carbomer homopolymer, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water, sodium hydroxide

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    ADAPALENE GEL

    ADAPALENE GEL USP, 0.1%

    ACNE TREATMENT

    • PREVIOUSLY AVAILABLE ONLY BY PRESCRIPTION
      • FDA-APPROVED
      • DERMATOLOGIST DEVELOPED
      • ONCE DAILY TOPICAL RETINOID*

    *Read consumer information leaflet before use

    Oil free

    Fragrance free

    Dermatologist developed and tested

    †COMPARE TO THE ACTIVE INGREDIENT IN DIFFERIN® GEL

    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.

    Manufactured by: Glenmark Pharmaceuticals Ltd.

    Colvale-Bardez, Goa 403513, India

  • Product Label

    Adapaene 0.1%

    Target Adapalene Gel

  • INGREDIENTS AND APPEARANCE
    ADAPALENE 
    adapalene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-888
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-888-151 in 1 CARTON11/01/2021
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09131411/01/2021
    Labeler - TARGET Corporation (006961700)