Berberex Wound Gel
FDA Label NDC 52261-0601

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Berberex Wound Gel (NDC 52261-0601). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, uses:, warnings:, do not use:, ask a doctor before use if you have:, when using this product:, stop use and ask a doctor if:, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

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