NDC Code(s) : 58231-002-01
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:58231-002
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 OXIDE2.2 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.6 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)
POLYGLYCERIN-3(UNII: 4A0NCJ6RD6)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CETYL RICINOLEATE(UNII: 1P677500YD)
GLYCERYL CAPRATE(UNII: 197M6VFC1W)
WHITE WAX(UNII: 7G1J5DA97F)
MAGNESIUM STEARATE(UNII: 70097M6I30)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
GLYCERIN(UNII: PDC6A3C0OX)
HEPTYL UNDECYLENATE(UNII: W77QUB6GXO)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BENZOIC ACID(UNII: 8SKN0B0MIM)
SORBIC ACID(UNII: X045WJ989B)
MAGNESIUM SULFATE(UNII: DE08037SAB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SENNA ALATA LEAF(UNII: 4BXR6YZN92)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58231-002-011 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