BURN-B GONE OTC - allantoin gel 
DeWitt Laboratories, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Burn-B Gone OTC 75g Tube

Active Ingredient:  Allantoin 1.0%

Purpose:  Skin Protectant

Temporarily protects skin after minor


For External Use Only

When using this product avoid contact with eyes.

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


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

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

Questions or comments?


Burn-B_Gone_OTC 75g Tube Artwork

allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51483-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin0.75 g  in 75 g
Inactive Ingredients
Ingredient NameStrength
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)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51483-002-2075 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2010
Labeler - DeWitt Laboratories, Inc (040211711)
Registrant - Quantum Labs LLC (932206126)
NameAddressID/FEIBusiness Operations
Quantum Labs LLC932206126manufacture

Revised: 6/2010
Document Id: 6e3069bd-e7ef-4f98-a0c7-18b7ce943776
Set id: 0061a03b-4886-44ae-a0e1-f0336ee5d2e6
Version: 1
Effective Time: 20100601
DeWitt Laboratories, Inc