NDC 0573-0246-25
API & Excipient Details

marketed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC under NDC Code 0573-0246-25

NDC Code(s) : 0573-0246-25, 0573-0246-26
Packager : GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ANBESOL COLD SORE THERAPYallantion, benzocaine, camphor, petrolatum OINTMENT

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-0246
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN(UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	10 mg in 1 g
BENZOCAINE(UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 g
CAMPHOR (SYNTHETIC)(UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg in 1 g
PETROLATUM(UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	649 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF(UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ISOCETYL STEARATE(UNII: 3RJ7186O9W)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
METHYLPARABEN(UNII: A2I8C7HI9T)
MINERAL OIL(UNII: T5L8T28FGP)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
WHITE WAX(UNII: 7G1J5DA97F)

Product Characteristics
Color	WHITE (White ointment)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-0246-25	1 in 1 BLISTER PACK	05/09/2006
1		9 g in 1 TUBE Type 0: Not a Combination Product
2	NDC:0573-0246-26	1 in 1 BLISTER PACK	15/09/2008
2		9 g in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/09/2006

LABELER - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC(079944263)

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