Label: NATURIUM BENZOYL PEROXIDE CLEANSER 5%- benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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

  • Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 5.00%

  • Purpose

    Acne Treatment

  • Uses

    • Helps fight existing acne breakouts and prevents future acne breakouts.
  • 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
    • 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.

    ​Keep out of reach of children.

  • Directions

    Shake Well.

    • gently massage a dime size amount on damp skin to cleanse thoroughly. Avoid eye area.
    • cover the entire affected area and rinse thoroughly.
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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

    Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above. Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

  • Inactive Ingredients

    Aqua (Water), Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Glycerin, Cocamidopropyl Hydroxysultaine, Acetyl Glucosamine, Aloe Barbadensis Leaf Juice, Sodium Methyl Cocoyl Taurate, Xylitol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Benzoate, Sodium Phosphate, Sodium Citrate, Propanediol, Diethylhexyl Sodium Sulfosuccinate, Carbomer, Sodium Hydroxide.

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    NATURIUM BENZOYL PEROXIDE CLEANSER 5% 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-123-011 in 1 CARTON06/17/2022
    1147 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00606/17/2022
    Labeler - e.l.f. Cosmetics, Inc (093902816)