Label: NEUTROGENA CLEAR PORE CLEANSER MASK- benzoyl peroxide gel

  • NDC Code(s): 69968-0026-4
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 5, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide (3.5%)

  • Purpose

    .Acne Medication

  • 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.

    Do not use if you

    • Have very sensitive skin.
    • Are sensitive to benzoyl peroxide.

    When using this product

    • Avoid unnecessary sun exposure and use a sunscreen.
    • Avoid contact with the eyes, lips and mouth.
    • Avoid contact with hair or dyed fabrics, 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.

    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

    • To use as a cleanser: Wet face. Squeeze into hands and gently massage all over the face, avoiding the eye area. Rinse thoroughly and pat dry.
    • To use as a mask: Do not exceed 2 to 3 times per week. Squeeze into hands. Smooth an even layer over skin, avoiding the eye area. Allow to dry up to 5 minutes. Rinse thoroughly and pat dry.
    • 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 - 25°C (68°F-77°F)

  • Inactive Ingredients

    Water, Glycerin, Kaolin, Bentonite, Sodium Methyl Cocoyl Taurate, Titanium Dioxide, Citric Acid, Xanthan Gum, Benzyl Alcohol, Sodium Citrate, Sodium Hydroxide, Fragrance, Disodium EDTA, Menthol

  • Questions?

    Call toll-free 800-582-4048 or 215-273-8755 (collect). www.neutrogena.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.

    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 125 mL Tube Label

    Clear
    Pore

    Cleanser/Mask

    Use as a
    Daily
    Cleanser
    to clear breakouts
    and blackhead-
    causing impurities

    Use as an
    Intensive
    Mask
    for deep
    cleansing and
    extra shine control

    Neutrogena ®
    benzoyl peroxide acne medication
    4.2 FL OZ (125 mL)

    Principal Display Panel - 125 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    NEUTROGENA CLEAR PORE CLEANSER MASK 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    BENTONITE (UNII: A3N5ZCN45C)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0026-4125 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/01/2016
    Labeler - Johnson & Johnson Consumer Inc. (118772437)