BURN-B GONE OTC - burn-b gone otc gel 
Quantum Labs LLC

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
Net Wt 2.5 oz (75 g)

NDC 47341-002-20

Skin Protectant Gel for
Doctor Recommended

Burn-B Gone OTC 75g Tube Artwork

burn-b gone otc gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47341-002
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:47341-002-2075 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/10/2010
Labeler - Quantum Labs LLC (932206126)
Registrant - Quantum Labs LLC (932206126)
NameAddressID/FEIBusiness Operations
Quantum Labs LLC932206126manufacture

Revised: 5/2010
Document Id: a6b5ed46-bf0e-4e9e-8ced-a6645ee59148
Set id: ace3557b-a08f-4a6e-b911-0bc2fa42141a
Version: 3
Effective Time: 20100519
Quantum Labs LLC