Label: ACNE TREATMENT CREAM cream

  • NDC Code(s): 84117-012-01
  • Packager: Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 3, 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

    Do not use this if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

  • When using this product

    keep away from eyes, lips and mouth

    wavoid unnecessary sun exposure and use a sunscreen
    avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
    skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly
    swelling. Mild irritation may be reduced by using the product less frequenty or in a lower concentration.
    Ifirritation becomes severe,discontinue use; ifirritation still continues, consulta doctor
    wusing other topical acne medication at the same time or immediately following the use of this product may
    increase dryness or iritation of the skin, lf this occurs, only one medication should be used unless directed
    by a doctor.

  • Keep Out Of Reach Of Children

    Keep out of reach of children.tfswallowed, get help or contact
    a Poison Control Center right away.Avoid contact with the eyes. lf contact occurs,flush thoroughly with water.

  • Directions Of Safe Use:

    Cleanse skin thoroughly before appying Acne Cream. Cover the enire afected
    area with a thin layer 1-3 times daiy. lf bothersome dryness or peeing occurs, reduce application to once a day.

  • Other information

    Keep tightly closed.Avoid storing at extreme temperatures (below 40° fand above 100° F).

  • Inactive ingredients

    water,carbomer,disodium EDTA, hydroxypropyl methylcellulose, laureth-4,sodium hydroxide,hyaluronic acid,
    niacinamide

  • DOSAGE & ADMINISTRATION

    ● adults and children 12 years of age and older:
    ● apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    ● brush teeth thoroughly for at least 1 minute twice a day (morning and evening),
    and not more than 3 times a day, or as recommended by a dentist or doctor.
    Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out
    after brushing.
    ● children under 12 years of age: Consult a dentist or doctor.

  • PRINCIPAL DISPLAY PANEL

    101112

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT CREAM 
    acne treatment cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84117-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84117-012-0150 g in 1 CANISTER; Type 0: Not a Combination Product07/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/03/2024
    Labeler - Shenzhen Hengkaifeng Commerce and Trade Co., Ltd (444722774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Hengkaifeng Commerce and Trade Co., Ltd444722774manufacture(84117-012) , label(84117-012)