FAMILY CARE ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [UNITED EXCHANGE CORP.]

FAMILY CARE ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [UNITED EXCHANGE CORP.]
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NDC 65923-006-00
Set ID a00105a8-549f-4006-929f-a2921230b2c9
Category HUMAN OTC DRUG LABEL
Packager UNITED EXCHANGE CORP.
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENT

    Active ingredient                                                                               Purpose

    Benzoyl Peroxide 10%......................................................................Acne medications

  • PURPOSE

    Uses

    • for the treatment and prevention of acne pimples
  • WARNINGS

    Warnings

    • for external use only
  • DO NOT USE

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

  • WHEN USING

    When using this product

    • 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
    • with other tropical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur.  If this occurs, only one medications should be use unless directed by a doctor
    • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling.  More frequent use or concentration may aggravate skin irritation.  Mild irritation may be reduced by using the product less frequently or in a lower concentration.
  • STOP USE

    Stop use and ask a doctor if skin irritation becomes severe

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    • cleanse the skin thoroughly before applying medication
    • cover the entire affected area with a thin layer one to three times a day
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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
    • use to prevent new pimples from forming
  • STORAGE AND HANDLING

    Other information

    • keep tightly closed
    • keep away from heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    bentonite, benzoyl peroxide, dimethicone, dried aluminum hydroxide gel, glyceryl stearate SE, isopropyl myristate, methylparaben, PEG-400, petrolatum, propylene glycol, propylparaben, tefose 63, water

  • DOSAGE & ADMINISTRATION

    Distributed by: Consumer Care Products Corp.

                          Cerritos, CA 90703 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ACNE TREATMENT 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-006
    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
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-006-001 in 1 CARTON
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/07/2012
    Labeler - UNITED EXCHANGE CORP. (840130579)

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