Burn-b Gone Otc
FDA Label NDC 51483-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dewitt Laboratories, Inc for the product Burn-b Gone Otc (NDC 51483-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - do not use, otc - stop use, 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

Otc - Active Ingredient

Active Ingredient:  Allantoin 1.0%

Otc - Purpose

Purpose:  Skin Protectant

Indications & Usage


Uses:
Temporarily protects skin after minor

  • burns
  • scrapes
  • cuts
    • Helps prevent, temporarily protects, and helps relieve chapped or cracked skin.
      • Helps prevent and protect skin from the drying effects of wind and cold weather.

Warnings


Warnings: 

For External Use Only


Otc - When Using

When using this product avoid contact with eyes.

Directions:
  • Adults and children 2 years of age and older - Cleanse affected area thoroughly.  Apply 3-4 times daily.
  • Children under 2 years old - Consult a doctor.

Otc - Do Not Use


Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms 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 right away.

Storage And Handling

Other Information:  Store between 15-30C (59-86F)

Inactive Ingredient

Inactive Ingredients:  Water (Aqua), SD Alcohol 40, Glycerin, Astragalus Gummifer Gum, Carbomer, Boric Acid, Disodium EDTA, Ethyl Ether, Triethanolamine, Methylparaben, Propylparaben

Otc - Questions


Questions or comments?

www.BurnBGoneOTC.com

* Please review the disclaimer below.