Label: ADAPALENE gel

  • NDC Code(s): 51672-2143-1, 51672-2143-6
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 13, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Adapalene USP, 0.1% (retinoid)1


    1
    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.

    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:
    Taro Pharmaceuticals
    U.S.A., Inc.

    Hawthorne, NY 10532

  • SPL UNCLASSIFIED SECTION

    Adapalene Gel USP, 0.1%
    Acne Treatment

    Frequently Asked Questions

    What is adapalene gel and what is it used for?

    • Adapalene gel is a topical retinoid medication used for the treatment of acne in people age 12 years and older.
    • Use only one time a day.

    What should I know before using the product?

    • If pregnant or breast-feeding, ask a doctor before use.
    • Some other retinoid drugs have been shown to cause birth defects. There is no specific evidence that adapalene gel 0.1% causes birth defects in humans when used topically as directed.
    • Do not use adapalene gel if you are allergic to adapalene or any of the ingredients in this product.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    How often do I apply the product?

    • Apply this product only one time a day and try to apply the product at the same time each day.

    How do I apply the product?

    • Gently clean the affected areas using a mild (non-irritating) cleanser and pat dry.
    • Apply adapalene gel as a thin layer to the affected areas of the skin only one time a day. For example, if you get acne on the face, clean, dry and apply the product to the entire face. Adapalene gel is not a spot treatment and should not be used to treat a single pimple.
    • Avoid product contact with eyes, lips and mouth. If contact occurs, immediately flush the area with water.
    • Do not apply product to damaged skin (cuts, abrasions, eczema, or sunburn).
    • Wash hands after use.

    How long will it take for adapalene gel to work?

    • It may take up to 3 months of daily use for results to appear.
    • 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.

    What do I do if I need to be in the sun?

    • When possible, limit sun exposure, including light from tanning beds.
    • When going outdoors, use sunscreen as labeled. Your skin may be more sensitive while using adapalene gel. If you use this product during the day, allow it to dry before applying sunscreen.

    Can I use a moisturizer if my skin is dry?

    • Yes, use of a moisturizer may help decrease dryness and other signs of irritation. Avoid products containing alpha hydroxy or glycolic acids which may worsen irritation.

    When is my skin most likely to become irritated? And what do I do?

    • Irritation (redness, itching, dryness, burning) is more likely to occur:
      • In the first few weeks of use.
      • If using abrasive skin cleansers, products with drying effects or more than one topical acne medication at a time. You may want to delay starting adapalene gel until any irritation from using the other product(s) has gone away.
    • Moisturizers may be used.
    • Irritation usually lessens after 4 weeks of continued use.

    What do I do if my skin becomes severely irritated?

    • If irritation becomes severe (overly bothersome), stop use and ask a doctor before using the product again.

    Can I remove unwanted facial hair by waxing while using this product?

    • Do not use wax to remove hair in areas where the product has been applied because it may worsen skin irritation.

    What ingredients are used in adapalene gel?

    • Adapalene gel contains:
      The active ingredient is adapalene USP, 0.1%. The other ingredients are: carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

    How should I store this product?

    • Adapalene gel should be stored at room temperature [68° to 77°F]. Protect from freezing.
    • Do not use the product after the expiry date marked on the packaging.

    Other Questions? Where can I get more information?
    Phone:
    1-866-923-4914

    Mfd. by: Taro Pharmaceuticals Inc.
    Brampton, Ontario, Canada L6T 1C1
    Made in Canada
    Issued: November 2021
    5225941 47

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    Compare to the
    active ingredient in
    Differin® Gel

    NDC 51672-2143-1

    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

    NET WT 0.5 OZ (15 g)

    PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ADAPALENE 
    adapalene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2143
    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:51672-2143-11 in 1 CARTON01/14/2022
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-2143-61 in 1 CARTON01/14/2022
    245 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21594001/14/2022
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2143)