Label: BERBEREX WOUND CLEANSER- benzethonium chloride liquid

  • NDC Code(s): 52261-0500-1, 52261-0500-2, 52261-0500-3
  • Packager: Cosco International, Inc.
  • 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 27, 2020

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  • Active Ingredient/Purpose

    Allantoin 0.5%........................Skin Protectant

    Benzethonium Chloride............Antiseptic

    Uses

    • helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips
    • topical antiseptic to help decrease the risk of skin infections
  • WARNINGS

    Warnings  For external use only.

  • Do not use 

    • in large quantities, particularly over raw surfaces or blistered areas
  • Ask doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Stop use and ask doctor if

    • condition worsens
    • symptons persist for more than 7 days or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions:

    Adults and children 2 years 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 2 years of age:  do not use, consult a doctor

  • Inactive ingredients:

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

  • PRINCIPAL DISPLAY PANEL

    118 mL PLPLDP118 mL PLPLDP118 mL PLPLDP

  • PRINCIPAL DISPLAY PANEL

    237 mL PLPLDP237 mL PLPLDP237 mL PLPLDP

  • PRINCIPAL DISPLAY PANEL

    473 mL PLPLDP

  • INGREDIENTS AND APPEARANCE
    BERBEREX WOUND CLEANSER 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0500
    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
    water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
    PANAX QUINQUEFOLIUS WHOLE (UNII: 0P067WOA1X)  
    hydrogen peroxide (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-0500-1118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2015
    2NDC:52261-0500-2237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2015
    3NDC:52261-0500-3473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/17/2015
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-0500) , label(52261-0500) , pack(52261-0500)
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