Label: CERAVE ACNE FOAMING CREAMWASH- benzoyl peroxide cream

  • NDC Code(s): 49967-604-01, 49967-604-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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

  • Active ingredient

    Benzoyl peroxide 10%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

  • Do not use if you

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

  • Stop use and ask a doctor if

    skin irritation becomes severe

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • use every morning and evening
    • apply a dime-size amount to damp skin and gently massage, avoiding the eye area
    • rinse well
    • use wash on entire affected area one to two 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.

  • Inactive ingredients

    water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium c14-16 olefin sulfonate, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, , niacinamide, glycolic acid, trideceth-6, triethyl citrate, sodium citrate, sodium hyaluronate, sodium hydroxide, sodium lauroyl lactylate, cholesterol, propanediol, tetrasodium EDTA, caprylyl glycol, diethylhexyl sodium sulfosuccinate, phytosphingosine, xanthan gum, acrylates/c10-30 alkyl acrylate crosspolymer, benzoic acid, PEG-30 dipolyhydroxystearate

  • Other information

    store at 20° - 25°C (68° to 77°F)

  • Questions orcomments?

    Toll-free number 1-888-768-2915

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
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    image of a carton
  • INGREDIENTS AND APPEARANCE
    CERAVE ACNE FOAMING CREAMWASH 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-604-011 in 1 CARTON12/01/2023
    1150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-604-021 in 1 CARTON12/01/2023
    210 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/01/2023
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, LLC061595175MANUFACTURE(49967-604)