Label: GOOD NEIGHBOR PHARMACY ACNE TREATMENT- benzoyl peroxide cream

  • 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 November 17, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                                               Purpose

    Benzoyl Peroxide 10% ....................................................Acne medication

  • 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 the eyes, lips and mouth
    • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
    • with other topical 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 medication should be used 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

    liquid paraffin, white petrolatum, cetanol, propylene glycol, stearyl alcohol, polyoxyethylancetylether, sorbitanmonostearate, polysorbate #60, methylparaben, butyl paraben, purified water

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Amerisource Bergen Corporation

    1300 Morris Drive

    Chesterbrook, PA 19087

    www.goodneighborpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY ACNE TREATMENT 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-4059
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-4059-21 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D11/17/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAI GUK PHARM. CO., LTD.631101656manufacture