Label: SNOWBERRY - zinc oxide, kaempferia galanga root, ethyl ferulate and larix sibirica wood cream

  • NDC Code(s): 58231-001-01
  • Packager: Snowberry New Zealand Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/14

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  • INACTIVE INGREDIENT

    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

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  • ACTIVE INGREDIENT

    Active Ingredients Zinc oxide, Caprylic Capric triglycerides,

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

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  • WARNINGS

    Avoid contact with eyes

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  • INGREDIENTS AND APPEARANCE
    SNOWBERRY 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58231-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1.6 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 Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58231-001-01 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(58231-001), relabel(58231-001), repack(58231-001)
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