NDC Code(s) : 17518-054-01
Packager : 3M Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

3M Nexcare Cold Sore Treatment3M Nexcare Cold Sore Treatment OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17518-054
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine(UNII: U3RSY48JW5)
(Benzocaine - UNII:U3RSY48JW5) 		Benzocaine50 mg in 1 g
Allantoin(UNII: 344S277G0Z)
(Allantoin - UNII:344S277G0Z) 		Allantoin10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
butylated hydroxytoluene(UNII: 1P9D0Z171K)
cetyl alcohol(UNII: 936JST6JCN)
edetate disodium(UNII: 7FLD91C86K)
ethyl oleate(UNII: Z2Z439864Y)
ethylparaben(UNII: 14255EXE39)
glycerin(UNII: PDC6A3C0OX)
menthol(UNII: L7T10EIP3A)
methylparaben(UNII: A2I8C7HI9T)
phenoxyethanol(UNII: HIE492ZZ3T)
propylparaben(UNII: Z8IX2SC1OH)
propylene glycol monolaurate(UNII: M4AW13H75T)
sodium ascorbyl phosphate(UNII: 836SJG51DR)
sodium hydroxide(UNII: 55X04QC32I)
sucralose(UNII: 96K6UQ3ZD4)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17518-054-012 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/20/2008

PRINCIPAL DISPLAY PANEL

Package Label

1 Tube

NET WT 2g (0.07 oz)

3M™ Nexcare™ Cold Sore Treatment

Benzocaine 5%
Allantoin 1 %

Skin Protectant

OTC Monograph

3M Consumer Health Care, 3M Center, St. Paul, MN 55144-1000

3M™ Nexcare™ Cold Sore Treatment - NET WT 2g (0.07 oz)

3M™ Nexcare™ Cold Sore Treatment - NET WT 2g (0.07 oz) - (front)3M™ Nexcare™ Cold Sore Treatment - NET WT 2g (0.07 oz) - (front)