Label: EQUATE BEAUTY ACNE FOAMING CLEANSER- benzoyl peroxide liquid

  • Category: HUMAN OTC DRUG LABEL

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 July 14, 2017

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  • Active ingredient

    Benzoyl Peroxide 10%

    Purpose

    Acne medication

  • Uses

    for the treatment and prevention of acne pimples

  • Warnings

    For external use only.

    Do not use if

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

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
    • avoid contact with eyes, lips and mouth
    • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by 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
    • 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 or redness becomes severe.

    Keep out of reach of children.
    • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
  • Directions

    • cleanse the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer and rinse thoroughly one to three 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
  • Other information

    • keep tightly closed
    • store at controlled room temperature 20°C-25°C (68°F-77°F)
  • Inactive ingredients

    Water (Aqua), Glyceryl Stearate SE, Cetearyl Alcohol, Cetyl Alcohol, Propylene Glycol, Cocamidopropyl Betaine, Glycerin, Lactic Acid, Benzyl Alcohol, Mineral Oil, Sodium Laureth Sulfate, PEG-100 Stearate, Glyceryl Stearate, Ceteareth-20, Polysorbate 60, Carbomer, Titanium Dioxide (CI 77891).

  • Questions or comments?

    1-888-287-1915

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    EQUATE BEAUTY ACNE FOAMING CLEANSER 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-132-05156 g in 1 TUBE; Type 0: Not a Combination Product07/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/13/2017
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(49035-132)
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