BERBEREX WOUND GEL- benzethonium chloride, allantoin gel 
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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BerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel

DRUG FACTS

Active Ingredient/Purpose:

Benzethonium Chloride (0.12%)..............Antiseptic

Allantoin (0.5%)...............................Skin Protectant

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 infection

Warnings:

For external use only.

Do not use:

• in the eyes
• over large areas of the body

Ask a doctor before use if you have:

• deep or puncture wounds
• deep cuts
• animal bites
• serious burns

When using this product:

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Apply only to the affected area. Avoid ingestion.

Stop use and ask a doctor if:

• Condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days

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:
• Clean minor cut, scrapes, or burns by thoroughly flushing the affected area with water or BerbereX® wound cleanser and let air dry
• Apply appropriate layer of the gel to cover the affected area
• Cover with adhesive bandage or sterile gauze if needed
• Apply 1 to 3 times daily
• Children under 2 years of age: ask a doctor

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, C13-14 Isoparaffin, Ethanol, Ethylhexylglycerin, Glycerin, Hydrastis Canadensis L., Hydrolyzed Bovine Collagen, Laureth-7, Panax Quinquefolius L., Phenoxyethanol, Sodium Acryloyldimethyltaurate-Acrylamide Copolymer, Sodium Hyaluronate, Sodium Hydroxide, Water

Storage and handling:

Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat
May discolor or stain certain fabrics

For Questions:

Call 1-888-252-6208
NuVision Pharmaceuticals, LLC.
4651 Roswell Rd., Suite G-601
Atlanta, GA 30342
Website: www.berberex.com

3oz tube label

BERBEREX WOUND GEL 
benzethonium chloride, allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.0012 kg  in 1 kg
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0050 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
LAURETH-7 (UNII: Z95S6G8201)  
PANAX QUINQUEFOLIUS WHOLE (UNII: 0P067WOA1X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-0601-10.0850 kg in 1 TUBE; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2022
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-0601) , label(52261-0601) , pack(52261-0601)

Revised: 6/2022
Document Id: 11d3d1e9-f1f6-4876-bfb0-8b8acfaf723f
Set id: 5dd97e65-bfb3-468e-a2b1-e56d30da99df
Version: 2
Effective Time: 20220630
 
Cosco International, Inc.