Label: BERBEREX WOUND CLEANSER- allantoin, benzethonium chloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 23, 2014

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  • ACTIVE INGREDIENT

    • Allantoin 0.5%
    • Benzethonium Chloride 0.1%
  • PURPOSE

    • Skin Protectant
    • Antiseptic
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center immediately.

  • USES

    helps protect skin and supports healing of minor cuts,

    scapes, bums and wounds, including pressure sores, diabetic

    ulcers, cracked skin and lips. topical antiseptic to help decrease

    the risk of skin infections

  • WARNINGS

    for external use only

    Do not use

    in large quantities, particularly over raw surfaces or blistered areas

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious bums

    Stop use and ask a doctor if

    • condition worsens
    • symptoms perist for more than 7days or clear up and occur again within a few days
  • DIRECTIONS

    Adults and children 2years of age and older

    Use to clean minor cut, scrapes and burns by thoroughly flushing the affected area; let air dry; cover with adhesive bandage or sterile gauze;  apply a small amount of this product on the area 1 to 3 times daily

    Children under 2years of age

    do not use, consult a doctor

  • INACTIVE INGREDIENTS

    Aloe barbadensis Mill, Ethanol, Hydrastis canadensis L., Hydrogen Peroxide, Panax quinquefolis L.

  • PRINCIPAL DISPLAY PANEL

    Display Panel
  • INGREDIENTS AND APPEARANCE
    BERBEREX WOUND CLEANSER 
    allantoin, benzethonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 g  in 1000 mL
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    PANAX QUINQUEFOLIUS WHOLE (UNII: 0P067WOA1X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-055-04118 mL in 1 BOTTLE
    2NDC:58133-055-08236 mL in 1 BOTTLE
    3NDC:58133-055-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2013
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty labs, Inc.032973000manufacture(58133-055)
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