Indications and 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
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
Label at a glance#
ProductBerberex Wound Gel
Active ingredientBENZETHONIUM CHLORIDE, ALLANTOIN
Label structure13 sections
Dosage and administration
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
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
Contacts and useful links#
Websitewww.berberex.com
www.berberex.com
www.berberex.comLabel contents#
Full prescribing information#
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
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:
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52261-0601-1 | 2025-03-28 | C162847 | 48780-1 | 2cef2736-83e1-d83d-e063-dadaa90ab31f | BerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel |
| 52261-0601-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-83e1-d83d-e063-dadaa90ab31f | BerbereX Wound Gel - Antimicrobial Skin & Wound Hydrogel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52261-0601-1 | Berberex Wound Gel | 0.0850 kg in 1 TUBE | GEL | 0.0850 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52261-0601 | BERBEREX WOUND GEL (BENZETHONIUM CHLORIDE, ALLANTOIN) GEL [COSCO INTERNATIONAL, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250331_5dd97e65-bfb3-468e-a2b1-e56d30da99df.zip |
Products#
Every source-derived product name is available through these pages.
- Berberex Wound Gel
- Benzethonium Chloride, Allantoin
- BENZETHONIUM CHLORIDE
- BENZETHONIUM
- ALLANTOIN
- ALOE VERA LEAF
- HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)
- C13-14 ISOPARAFFIN
- ALCOHOL
- ETHYLHEXYLGLYCERIN
- GLYCERIN
- HYDRASTIS CANADENSIS WHOLE
- LAURETH-7
- PANAX QUINQUEFOLIUS WHOLE
- PHENOXYETHANOL
- SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)
- HYALURONATE SODIUM
- SODIUM HYDROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52261-0601 | 52261-0601-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Berberex Wound Gel | BENZETHONIUM CHLORIDE, ALLANTOIN | Cosco International, Inc. | 5dd97e65-bfb3-468e-a2b1-e56d30da99df | 2025-03-28 | Warnings | 52261-0601-1 52261-0601 52261060101 67cabb40-44f2-4ad0-ad14-77f4ab2bd1dc 5dd97e65-bfb3-468e-a2b1-e56d30da99df |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.