Burn-B Gone OTC by Quantum Labs LLC BURN-B GONE OTC gel

Burn-B Gone OTC by

Drug Labeling and Warnings

Burn-B Gone OTC by is a Otc medication manufactured, distributed, or labeled by 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

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

NDC: 47341-002-20

Skin Protectant Gel for

• Burns
• Cuts
• Scrapes

Doctor Recommended

INGREDIENTS AND APPEARANCE

BURN-B GONE OTC 
burn-b gone otc gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47341-002
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: 47341-002-20	75 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/10/2010

Labeler - Quantum Labs LLC (932206126)

Registrant - Quantum Labs LLC (932206126)

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