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Burn-B Gone OTC by Quantum Labs LLC

Medically reviewed on May 21, 2018

Dosage form: gel
Ingredients: Allantoin 0.75g in 75g
Labeler: Quantum Labs LLC
NDC Code: 47341-002

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


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: 

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.


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.


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?

www.BurnBGoneOTC.com


Burn-B Gone OTC
Net Wt 2.5 oz (75 g)

NDC 47341-002-20

Skin Protectant Gel for
  • Burns
  • Cuts
  • Scrapes
Doctor Recommended


BURN-B GONE OTC 
burn-b gone otc gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47341-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (Allantoin) Allantoin0.75 g  in 75 g
Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 
Glycerin 
Tragacanth 
Carbomer Homopolymer Type C 
Boric Acid 
Edetate Disodium 
Ether 
Trolamine 
Methylparaben 
Propylparaben 
Packaging
#Item CodePackage Description
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)
Establishment
NameAddressID/FEIOperations
Quantum Labs LLC932206126manufacture

 
Quantum Labs LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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