FDA Label for Burn-b Gone Otc

View Indications, Usage & Precautions

Burn-b Gone Otc Product Label

The following document was submitted to the FDA by the labeler of this product Dewitt Laboratories, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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