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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58231-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE1.6 g  in 10 g
KAEMPFERIA GALANGA ROOT (KAEMPFERIA GALANGA ROOT) KAEMPFERIA GALANGA ROOT.7 g  in 10 g
ETHYL FERULATE (ETHYL FERULATE) ETHYL FERULATE.7 g  in 10 g
LARIX SIBIRICA WOOD (LARIX SIBIRICA WOOD) LARIX SIBIRICA WOOD.3 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITAN OLIVATE 
CETYL PALMITATE 
COCO GLUCOSIDE 
GLYCERIN 
ARABICA COFFEE OIL 
SHEA BUTTER 
INGA EDULIS SEED 
BRASSICA RAPA VAR. RAPA 
STEARIC ACID 
GLUCOSE OXIDASE 
SENNA ALATA WHOLE 
ALOE VERA WHOLE 
GUAR GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58231-001-011 in 1 CARTON
150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2013
Labeler - Snowberry New Zealand Ltd (594018264)
Establishment
NameAddressID/FEIBusiness Operations
Snowberry New Zealand Ltd594018264manufacture(58231-001), relabel(58231-001), repack(58231-001)

Revised: 4/2014
Document Id: 4d01bfba-2dd9-4951-a761-8aa6f4f697bc
Set id: cb947c9e-9147-4c83-8a64-5f3d1791c8c7
Version: 1
Effective Time: 20140417
 
Snowberry New Zealand Ltd