BERBEREX WOUND CLEANSER- benzethonium chloride liquid 
Cosco International, Inc.

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.

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Drug Facts

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  For external use only.

Do not use 

Ask doctor before use if you have

Stop use and ask doctor if

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:

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

118 mL PLPLDP118 mL PLPLDP118 mL PLPLDP

237 mL PLPLDP237 mL PLPLDP237 mL PLPLDP

473 mL PLPLDP

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)

Revised: 1/2020
Document Id: af7d3c7f-8c60-405d-9d52-6c040ac81e3a
Set id: 08b28f52-21fc-4694-a163-91c8193b4008
Version: 5
Effective Time: 20200127
 
Cosco International, Inc.