SNOWBERRY  - zinc oxide, kaempferia galanga root, ethyl ferulate and larix sibirica wood cream 
Snowberry New Zealand Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Ingredients Agua (Demineralised), Sorbitan Olivate (Olive),

Cetyl Palmitate, Sorbitan Palmitate, Coco Glucoside, Cetrary Alcohol (wheat extract), Glycerin (Coconut),

Coffea Arabica (Coffee Bean) oil, Butyrosperum parkii (shea Butter), Inga edulis (Inga) seed extract,

Brassica Campestris (Rapeseed) oil, Stearic Acid, Glycerin, Glycin Soja (soybean oil), Glucose,

Glucose Oxidase, Lactoperoxidase, Porphyraumbilicasis (Seaweed) extract,

Cassia Alata leaf extract, Aloe barbadensis leaf extract, Guar Gum,

Tocopherol (mixed), Beta-Sitosterol, Squalene (sunflower), Sclerotium Gum

Active Ingredients Zinc oxide, Caprylic Capric triglycerides,

Kaempferia Galanga Root extract, Ethyl Fenulate, Larix Sabirica (Siberian larch) extract

Avoid contact with eyes

copy of label

SNOWBERRY  
zinc oxide cream
Product Information
Product Type HUMAN OTC 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 OXIDE 2.2 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
1 NDC:58231-002-01 1 in 1 CARTON
1 50 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
Labeler - Snowberry New Zealand Ltd (594018264)
Establishment
Name Address ID/FEI Business Operations
Snowberry New Zealand Ltd 594018264 manufacture(58231-002) , relabel(58231-002) , repack(58231-002)

Revised: 4/2014
Document Id: 4de0e878-6b0f-40c5-ad03-c3c2ba54b9af
Set id: a5c7025b-b286-40d6-a3f0-068913647e5f
Version: 1
Effective Time: 20140420
 
Snowberry New Zealand Ltd