NDC 51483-002 Burn-b Gone Otc

Product Information

What is NDC 51483-002?

The NDC code 51483-002 is assigned by the FDA to the product Burn-b Gone Otc which is product labeled by Dewitt Laboratories, Inc. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 51483-002-20 75 g in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code51483-002
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Burn-b Gone Otc
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Dewitt Laboratories, Inc
Labeler Code51483
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-01-2010
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2017
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Burn-b Gone Otc?


Product Packages

NDC Code 51483-002-20

Package Description: 75 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Burn-b Gone Otc Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Burn-b Gone Otc Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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Burn-b Gone Otc Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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.