Label: NEUTROGENA STUBBORN ACNE AM TREATMENT- benzoyl peroxide gel

  • NDC Code(s): 69968-0653-1, 69968-0653-2
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide (2.5%)

  • Purpose

    Acne treatment

  • Use

    For the treatment of acne.

  • Warnings

    For external use only.

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips and mouth. If contact occurs, flush thoroughly with water
    • avoid contact with hair or dyed products, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide.

    Stop use and ask a doctor if

    • Irritation becomes severe.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other Information

    • Store at 20°C to 25°C (68°F - 77°F)
  • Inactive ingredients

    Water, Carbomer Homopolymer type B, Ethylhexylglycerin, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Laureth-4, Hydroxypropyl Methylcellulose

  • Questions?

    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 - 56 g Tube Carton

    New
    Neutrogena ®
    DERMATOLOGIST RECOMMENDED BRAND
    STUBBORN
    ACNE
    AM TREATMENT
    Benzoyl Peroxide
    Acne treatment

    works all day to help
    eliminate stubborn acne

    2.5% Micronized BPO

    NET WT. 2.0 OZ
    (56 g)

    PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NEUTROGENA STUBBORN ACNE AM TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0653
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-4 (UNII: 6HQ855798J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0653-21 in 1 CARTON08/03/2020
    156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69968-0653-112 in 1 PACKAGE08/03/2020
    29 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/03/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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