Label: CERAVE ACNE FOAMING CLEANSER- benzoyl peroxide cream

  • NDC Code(s): 49967-238-01, 49967-238-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 31, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Benzoyl peroxide 4%

  • 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 wel
    • 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, xanthan gum, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycolic acid, sodium chloride, sodium citrate, sodium hyaluronate, sodium lauroyl lactylate, sodium hydroxide, cholesterol, phenoxyethanol, propanediol, citric acid, tetrasodium EDTA, diethylhexyl sodium sulfosuccinate, phytosphingosine, ethylhexylglycerin, benzoic acid

  • 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
    image of a carton
  • INGREDIENTS AND APPEARANCE
    CERAVE ACNE FOAMING CLEANSER 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-238
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE40 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)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    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)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-238-011 in 1 CARTON12/01/2021
    1150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-238-0215 in 1 CARTON12/01/2021
    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 DrugM00612/01/2021
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, LLC061595175MANUFACTURE(49967-238)