Label: DIFFERIN- adapalene gel

  • NDC Code(s): 0299-4910-00, 0299-4910-10, 0299-4910-15, 0299-4910-40, view more
    0299-4910-45
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 15, 2020

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

  • Drug Facts

    Active ingredient
    Adapalene 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.

    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 room temperature 68°-77°F
    • protect from freezing
  • Inactive Ingredients

    carbomer 940, edetate disodium, methylparaben, poloxamer 182,
    propylene glycol, purified water and sodium hydroxide.
    May contain hydrochloric acid to adjust pH.

  • Questions? 1-866-735-4137

  • Patient Leaflet

    DIFFERIN GEL
    ADAPALENE GEL 0.1%
    ACNE TREATMENT

    Frequently Asked Questions

    What is Differin and what is it used for?

    • Differin Gel is a topical retinoid medication used for the treatment of acne in people 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 Differin Gel 0.1% causes birth defects in humans when used topically as directed.
    Do not use Differin 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 Differin 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. Differin 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 Differin 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.

    DIFFERIN GEL
    ADAPALENE GEL 0.1%
    ACNE TREATMENT
    Frequently Asked Questions (Continued)

    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 a sunscreen as labeled. Your skin may be more sensitive when using Differin 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 hydroxyl 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 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 Differin 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 Differin?

    • Differin Gel contains:
    The active ingredient is adapalene 0.1%. The other ingredients are: carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid to adjust pH.

    How should I store this product?

    • Differin Gel should be stored at room temperature [68° - 77°]. Protect from freezing.
    • Do not use the product after the expiry date marked on the packaging.

    Other Questions? Where can I get information?
    Phone: 1-866-735-4137

    P54379-0

    P54379-0 Differin 0.1 Gel Insert Page 1
    P54379-0 Differin 0.1 Gel Insert Page 2
  • PRINCIPAL DISPLAY PANEL - 45g Carton (Tube)

    DIFFERIN® GEL

    ADAPALENE GEL 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 1.6 OZ (45 g)

    Distributed by:
    Galderma Laboratories, L.P.
    A Nestlé Skin Health Company
    Fort Worth, TX 76177 USA

    Made in Canada

    All trademarks are the property of their respective owners.

    P53824-2

    P53824-2 Differin 0.1 Gel Carton
  • PRINCIPAL DISPLAY PANEL - 45g Carton (Pump)

    DIFFERIN® GEL

    ADAPALENE GEL 0.1%
    ACNE TREATMENT

    • Previously available only by prescription

    • FDA approved

    • Dermatologist developed

    • Once Daily Topical Retinoid*

    * Read consumer information leaflet before use

    Easy to use PUMP

    NET WT 1.6 OZ (45 g)

    Distributed by:
    Galderma Laboratories, L.P.
    Fort Worth, TX 76177 USA

    Made in Canada

    All trademarks are the property of their respective owners.

    P54378-1

    P54378-1 Differin 0.1 Gel pump carton
  • INGREDIENTS AND APPEARANCE
    DIFFERIN  
    adapalene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4910
    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)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4910-451 in 1 CARTON07/08/2016
    145 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0299-4910-151 in 1 CARTON07/08/2016
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0299-4910-001 in 1 BLISTER PACK07/08/2016
    32 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0299-4910-101 in 1 CARTON01/01/2020
    415 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    5NDC:0299-4910-401 in 1 CARTON01/01/2020
    545 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02038007/08/2016
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961MANUFACTURE(0299-4910)