Label: NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT- adapalene gel

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

Drug Label Information

Updated November 12, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    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 the eyes, lips, and mouth. If contact occurs, immediately flush the area with water.

    ▪ wash hands after use

    Stop use and ask a 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 (1-800-222-1222) right away.

  • Directions

    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° to 77°F

    ▪ protect from freezing

  • Inactive ingredients

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

    May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or comments?

    Call 800-582-4048; Outside US, dial collect

    215-273-8755 or visit www.neutrogena.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    JOHNSON & JOHNSON

    CONSUMER INC.


    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

    Neutrogena ®

    DERMATOLOGIST RECOMMENDED BRAND

    NEW

    Adapalene

    Gel 0.1%

    Acne Treatment

    Previously available only

    By prescription

    Dermatologist developed

    & tested

    Once Daily Topical

    Retinoid*

    Oil Free

    Fragrance Free

    *Read consumer information

    leaflet before use

    NET WT 1.6 OZ (45 g)

    Neutrogena_01

  • INGREDIENTS AND APPEARANCE
    NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT 
    adapalene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0826
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLOXAMER 182 (UNII: JX0HIX6OAG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0826-11 in 1 CARTON12/04/2023
    145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09096212/04/2023
    Labeler - Kenvue Brands LLC (118772437)