Berberex Wound Cleanser Liquid
FDA Label NDC 52261-0500

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 Cleanser (NDC 52261-0500). 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, uses, warnings, do not use, ask doctor before use if you have, stop use and ask doctor if, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient/Purpose

Allantoin 0.5%........................Skin Protectant

Benzethonium Chloride............Antiseptic

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 skin infections

Warnings

Warnings  For external use only.

Do Not Use

  • in large quantities, particularly over raw surfaces or blistered areas

Ask Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop Use And Ask Doctor If

  • condition worsens
  • symptons persist for 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:

  • 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 2 years of age:  do not use, consult a doctor

Inactive Ingredients:

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

Package Label.Principal Display Panel

118 mL Plpldp (Mm1)

118 mL Plpldp (Mm1)

118 mL Plpldp (Mm1)

118 mL Plpldp (Mm1)

118 mL Plpldp (Mm1)

118 mL Plpldp (Mm1)

237 mL Plpldp (Mm2)

237 mL Plpldp (Mm2)

237 mL Plpldp (Mm2)

237 mL Plpldp (Mm2)

237 mL Plpldp (Mm2)

237 mL Plpldp (Mm2)

473 mL Plpldp (Mm3)

473 mL Plpldp (Mm3)

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