Label: BURN-B GONE OTC gel
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Contains inactivated NDC Code(s)
NDC Code(s): 47341-002-20 - Packager: Quantum Labs LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 19, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURN-B GONE OTC
burn-b gone otc gelProduct 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