Label: 5 PERCENT BENZOYL PEROXIDE CLEANSER- benzoyl peroxide gel

  • NDC Code(s): 81136-023-01
  • Packager: Brand Evangelists for Beauty Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredients

    Benzoyl Peroxide 5%

  • Purpose

    Acne Medication

  • Uses

    • 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

    irritation becomes severe.

    If pregnant or breastfeeding

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    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 below.• wet area to be cleansed • apply acne wash and gently massage area for 1-2 minutes • rinse thoroughly and pat dry • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 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 a broad spectrum sunscreen after using this product • if irritation or sensitivity develops, stop use of both products and ask a doctor.

  • Inactive ingredients

    Aqua (Water), Glycerin, Sodium Laurylglucosides Hydroxypropylsulfonate, Decyl Glucoside, Stearic Acid, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6, Sodium Chloride, Ethylhexylglycerin, SodiumHydroxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate, t-Butyl Alcohol.

  • Questions or Comments?

    Call toll free (833) 981-2335

  • Package Labeling:

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  • INGREDIENTS AND APPEARANCE
    5 PERCENT BENZOYL PEROXIDE CLEANSER 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81136-023
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAUROYL HYDROXYPROPYL SULFONATE (UNII: IQ398K5X8M)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81136-023-011 in 1 CARTON08/24/2022
    1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/24/2022
    Labeler - Brand Evangelists for Beauty Limited (222990724)
    Registrant - Orean Personal Care Ltd. (211403363)
    Establishment
    NameAddressID/FEIBusiness Operations
    Orean Personal Care Ltd.211403363manufacture(81136-023)
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