BERBERX WOUND CLEANSER- allantoin and benzethonium chloride solution 
Cosmetic Specialty labs, 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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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
BERBERX WOUND CLEANSER 
allantoin 0.5%, benzethonium chloride 0.1% solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58133-055
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN5 g  in 1000 mL
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE1 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA WHOLE  
ALCOHOL  
HYDRASTIS CANADENSIS WHOLE  
Hydrogen Peroxide 
PANAX QUINQUEFOLIUS WHOLE 
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)

Revised: 8/2013
Document Id: 648d9a29-ebe7-42c3-bda3-d4aeaadc5091
Set id: cd8c1230-f356-4587-8e49-4c7db6e09849
Version: 1
Effective Time: 20130826
 
Cosmetic Specialty labs, Inc.