Label: ADAPALENE gel

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

Drug Label Information

Updated November 17, 2021

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

  • Active ingredient

    Agapalene 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 415.294.0377

  • Principal Display Panel

    ADAPALENE GEL USP, 0.1%

    FDA-APPROVED | ONCE DAILY

    TOPICAL RETINOID*

    DERMATOLOGIST DEVELOPED

    Previously available only by prescription

    First FDA-Approved over-the-counter topical retinoid* for acne treatment

    Keep this carton and consumer information leaflet. They contain important information.

    *Read carton and enclosed consumer information leaflet before using this product.

    Fragrance free and oil free

    NET WT OZ (g)

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY:

    Stryke Club, Inc.

    Los Angeles, CA 90069

    WWW.STRYKECLUB.COM

  • Product Label

    Adapalene USP 0.1% (retinoid)* *read consumer information leaflet

    STRYKE CLUB Adapalene Gel

  • INGREDIENTS AND APPEARANCE
    ADAPALENE 
    adapalene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82034-888
    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:82034-888-051 in 1 CARTON11/12/2021
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09131411/12/2021
    Labeler - Stryke Club, Inc. (117541253)