BURN-B GONE OTC- allantoin gel

Burn-B Gone OTC by

Drug Labeling and Warnings

Burn-B Gone OTC by is a Otc medication manufactured, distributed, or labeled by DeWitt Laboratories, Inc, Quantum Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:  Allantoin 1.0%

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

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.

WHEN USING

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.

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

QUESTIONS

Questions or comments?

www.BurnBGoneOTC.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN-B GONE OTC 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51483-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	0.75 g  in 75 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51483-002-20	75 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2010

Labeler - DeWitt Laboratories, Inc (040211711)

Registrant - Quantum Labs LLC (932206126)

Establishment
Name	Address	ID/FEI	Business Operations
Quantum Labs LLC		932206126	manufacture