Label: DR ACNE WASH FACIAL CLEANSER- benzoyl peroxide cream

  • NDC Code(s): 63742-020-00
  • Packager: Clinical Resolution Laboratory, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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

  • DRUG FACTS

  • Active Ingredient

    Benzoyl Peroxide 10%

    Purpose

    Acne Treatment

  • Uses:

    for the treatment of acne.

  • Warnings

    For external use only

    Do not use

    • if you are sentitive to Benzoyl Peroxide or have very sensitive skin.
    • using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin.
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    When using this product

    • avoid contact with and near eyes. If contact occurs, flush thoroughly with water.
    • keep away from lips and mouth.
    • avoid unnecessary sun exposure and use a sunscreen.
    • avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

    Stop use and ask doctor if

    irritation becomes severe and continues

    Keep out of reach of children

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

  • Other information

    Keep tightly closed when not in used. Store at room temperature 20°- 30°C (68°- 86°F)

  • Directions

    Apply a dime to quarter-sized amount and gently massage into damp skin, avoiding area near eyes. Wait 1~2 minutes (If can be tolerated, then 3~5 minutes) to allow wash to absorb, then rinse thoroughly with warm water. Follow with oil free moisturizer over skin to nourish and rehydrate and to soothe irritation and prevent flakiness. Apply at least SPF 30 sunscreen if going outside.

  • Inactive ingredients

    Cannabis Sativa (Hemp) Seed Oil, Carbomer, Centella Asiatica Extract, Cocamidopropyl Betaine, Dimethyl Isosorbide, Fragrance, Glycerin, Isododecane, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium Hydroxide

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DR ACNE WASH FACIAL CLEANSER 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-020-00237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/15/2019
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clinical Resolution Laboratory, Inc.825047942manufacture(63742-020) , label(63742-020) , pack(63742-020)