NDC Code(s) : 45334-301-02, 45334-301-35
Packager : Pharmaceutical Specialties, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Vanicream Diaper RashDimethicone, Zinc Oxide OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45334-301
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE11 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION400 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
C30-45 ALKYL METHICONE(UNII: NFX970DSI2)
C30-45 OLEFIN(UNII: 6DWD51M0O8)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45334-301-021 in 1 CARTON 30/06/2014
170 g in 1 TUBE Type 0: Not a Combination Product
2NDC:45334-301-3510 g in 1 TUBE Type 0: Not a Combination Product30/06/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/30/2014 03/31/2019

PRINCIPAL DISPLAY PANEL

NDC 45334-301-02

PEDIATRICIAN/DERMATOLOGIST RECOMMENDED

Kid Friendly

Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives

MAXIMUM STRENGTH

Net Wt 2.5 oz (70 g)

Vanicream Diaper Rash Box