NDC Code(s) : 58231-001-01
Packager : Snowberry New Zealand Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Snowberry Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58231-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.6 g in 10 g
KAEMPFERIA GALANGA ROOT(UNII: 7B7U9D12AI)
(KAEMPFERIA GALANGA ROOT - UNII:7B7U9D12AI) 		KAEMPFERIA GALANGA ROOT.7 g in 10 g
ETHYL FERULATE(UNII: 5B8915UELW)
(ETHYL FERULATE - UNII:5B8915UELW) 		ETHYL FERULATE.7 g in 10 g
LARIX SIBIRICA WOOD(UNII: KSC3PGF73L)
(LARIX SIBIRICA WOOD - UNII:KSC3PGF73L) 		LARIX SIBIRICA WOOD.3 g in 10 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SORBITAN OLIVATE(UNII: MDL271E3GR)
CETYL PALMITATE(UNII: 5ZA2S6B08X)
COCO GLUCOSIDE(UNII: ICS790225B)
GLYCERIN(UNII: PDC6A3C0OX)
ARABICA COFFEE OIL(UNII: IK55HKE887)
SHEA BUTTER(UNII: K49155WL9Y)
INGA EDULIS SEED(UNII: GC3TZ3X7A4)
BRASSICA RAPA VAR. RAPA(UNII: AIV6895O8B)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLUCOSE OXIDASE(UNII: 0T8392U5N1)
SENNA ALATA WHOLE(UNII: G8NM9MK16J)
ALOE VERA WHOLE(UNII: KIZ4X2EHYX)
GUAR GUM(UNII: E89I1637KE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58231-001-011 in 1 CARTON
150 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/01/2013

PRINCIPAL DISPLAY PANEL

copy of label