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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLANTOIN(UNII: 344S277G0Z)
(ALLANTOIN - UNII:344S277G0Z) 		ALLANTOIN10 mg in 1 g
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE200 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) 		PETROLATUM649 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0573-0246-251 in 1 BLISTER PACK 05/09/2006
19 g in 1 TUBE Type 0: Not a Combination Product
2NDC:0573-0246-261 in 1 BLISTER PACK 15/09/2008
29 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/09/2006

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

PRINCIPAL DISPLAY PANEL

ointment
WITH
Vitamin E
& Aloe

See new warnings information

Anbesol®
Fever Blister/Cold Sore Treatment

Cold Sore THERAPY

MAXIMUM
STRENGTH

DOCTOR
RECOMMENDED

Instant
Pain Relief

  • 1.Cold Sores and
    Fever Blisters
  • 2.Moisturizes While It
    Treats and Protects

NET WT 0.33 OZ (9 g)

Safety Sealed Tube:
Do Not Use if tube tip is cut prior to opening.

Principal Display Panel - 9 g Tube Blister Pack Label