Label: CLEAN AND CLEAR ADVANTAGE ACNE CONTROL CLEANSER- benzoyl peroxide cream

  • NDC Code(s): 69968-0033-1
  • 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 21, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 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 and 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.

    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

    • Wet face. Gently massage all over face, avoiding eye area. Rinse thoroughly and pat dry.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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, Cetyl Alcohol, Petrolatum, Zinc Lactate, Steareth-2, Glycerin, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Benzyl Alcohol, Fragrance, Disodium EDTA, Laureth-4, BHT, Menthol

  • Questions?

    Call toll-free 877-754-6411 or215-273-8755 (collect) or visit www.cleanandclear.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.

    Skillman, NJ 08558-9418

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    Clean
    &
    Clear ®
    ®

    advantage
    acne control
    cleanser

    benzoyl peroxide acne treatment

    DAILY FORMULA

    clears and helps
    prevent breakouts

    penetrates pores to help
    stop acne before it starts

    Johnson & Johnson

    NET WT. 4 OZ. (113 g)

    Principal Display Panel - 113 g Tube Label
  • INGREDIENTS AND APPEARANCE
    CLEAN AND CLEAR ADVANTAGE ACNE CONTROL CLEANSER 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-4 (UNII: 6HQ855798J)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0033-1113 g in 1 TUBE; Type 0: Not a Combination Product10/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2015
    Labeler - Johnson & Johnson Consumer Inc. (002347102)