Adapalene by YYBA CORP / Taro Pharmaceuticals U.S.A., Inc. / Taro Pharmaceuticals Inc. ADAPALENE gel

Adapalene by

Drug Labeling and Warnings

Adapalene by is a Otc medication manufactured, distributed, or labeled by YYBA CORP, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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.

    If pregnant or breast-feeding, 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 becomes 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 results
    • avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.
    • wash hands after use

    Stop use and ask doctor if

    • you become pregnant, or are planning to become pregnant, while using the product
    • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
    • irritation becomes 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 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 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 or better results, but may worsen skin irritation.

    Children under 12 years of age: ask a doctor

  • Other information

    • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
    • protect from freezing
  • Inactive ingredients

    carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

  • Questions?

    1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Wellspring
    Airmont, NY 10952, U.S.A.

  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

    welmate

    Compare to the
    active ingredient
    in Differin® Gel†

    Adapalene Gel
    USP, 0.1%

    Acne Treatment

    ONCE DAILY TOPICAL RETINOID*

    PREVIOUSLY AVAILABLE
    ONLY BY PRESCRIPTION

    DERMATOLOGIST
    DEVELOPED

    FDA APPROVED

    * Read consumer information leaflet before use

    NET WT 45 g (1.6 oz)

    PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ADAPALENE 
    adapalene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73581-214
    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: 73581-214-061 in 1 CARTON10/15/2023
    145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21594010/15/2023
    Labeler - YYBA CORP (006339772)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(73581-214)
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