FDA.reportPublic FDA data

Berberex Wound Gel

Manufacturer
Cosco International, Inc.
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:08

Key Label Information#

Active Ingredients And Purpose

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

Uses

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

Do not use:

• in the eyes • over large areas of the body

Warnings

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

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

Directions And Dosage

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

Other Label Information

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

Label Images#

berberex hydrogel label 3oz
berberex hydrogel label 3oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-0601-12025-03-28C16284748780-12cef2736-83e1-d83d-e063-dadaa90ab31fBerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel
52261-0601-12025-01-30C16284748780-12cef2736-83e1-d83d-e063-dadaa90ab31fBerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0601-1Berberex Wound Gel0.0850 kg in 1 TUBEGEL0.08503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0601BERBEREX WOUND GEL (BENZETHONIUM CHLORIDE, ALLANTOIN) GEL [COSCO INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20250331_5dd97e65-bfb3-468e-a2b1-e56d30da99df.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-060152261-0601-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744ACTIB
ALLANTOIN344S277G0ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)5WE8P977RQIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ALCOHOL3K9958V90MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
HYDRASTIS CANADENSIS WHOLER763EBH88TIACT
LAURETH-7Z95S6G8201IACT
PANAX QUINQUEFOLIUS WHOLE0P067WOA1XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)5F4963KLHSIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Complete SPL Sections#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient/Purpose: Benzethonium Chloride (0.12%)..............Antiseptic Allantoin (0.5%)...............................Skin Protectant

Uses:

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

For external use only.

Do not use:

Indications & Usage Section

• in the eyes • over large areas of the body

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

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

When using this product:

OTC - WHEN USING SECTION

• 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:

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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:

SPL UNCLASSIFIED SECTION

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:

OTC - QUESTIONS SECTION

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

Source Document#

Source XML