NDC 51483-002 Burn-b Gone Otc

NDC Product Code 51483-002

NDC 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.

NDC Product Information

Burn-b Gone Otc with NDC 51483-002 is a product labeled by Dewitt Laboratories, Inc. The generic name of Burn-b Gone Otc is . The product's dosage form is and is administered via form.

Labeler Name: Dewitt Laboratories, Inc

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TRAGACANTH (UNII: 2944357O2O)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHER (UNII: 0F5N573A2Y)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dewitt Laboratories, Inc
Labeler Code: 51483
Start Marketing Date: 06-01-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 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.

Exclude Flag: I 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Burn-b Gone Otc Product Label Images

Burn-b Gone Otc Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredient:  Allantoin 1.0%

Otc - Purpose

Purpose:  Skin Protectant

Indications & Usage

  • Uses:Temporarily protects skin after minorburnsscrapescutsHelps 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 ondeep or puncture woundsanimal bitesserious burns

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms 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.