BERBEREX WOUND GEL- benzethonium chloride, allantoin gel

Berberex Wound Gel by

Drug Labeling and Warnings

Berberex Wound Gel by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BERBEREX WOUND GEL 
benzethonium chloride, allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-0601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.0012 kg  in 1 kg
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.0050 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-0601-1	0.0850 kg in 1 TUBE; Type 0: Not a Combination Product	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2022

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-0601) , label(52261-0601) , pack(52261-0601)