Berberex Wound Cleanser
FDA Label NDC 58133-055

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Berberex Wound Cleanser (NDC 58133-055). 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 active ingredient, purpose, keep out of reach of children, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

  • Allantoin 0.5%
  • Benzethonium Chloride 0.1%

Purpose

  • Skin Protectant
  • Antiseptic

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a poison control center immediately.

Uses

helps protect skin and supports healing of minor cuts,

scapes, bums and wounds, including pressure sores, diabetic

ulcers, cracked skin and lips. topical antiseptic to help decrease

the risk of skin infections

Warnings

for external use only

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious bums

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms perist for more than 7days or clear up and occur again within a few days

Directions

Adults And Children 2Years Of Age And Older

Use to clean minor cut, scrapes and burns by thoroughly flushing the affected area; let air dry; cover with adhesive bandage or sterile gauze;  apply a small amount of this product on the area 1 to 3 times daily

Children Under 2Years Of Age

do not use, consult a doctor

Inactive Ingredients

Aloe barbadensis Mill, Ethanol, Hydrastis canadensis L., Hydrogen Peroxide, Panax quinquefolis L.

Principal Display Panel

Display Panel (Berberex 01)

Display Panel (Berberex 01)

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