Label: NATURALLY NOVA SCOTIA HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 8, 2009

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Ethyl Alcohol* (Antiseptic) 62%

  • USES:

    To decrease bacteria on the skin that could cause disease.
    Recommended for repeated use.  Kills 99.9% of common harmful
    germs and bacteria within 30 seconds.
  • Cautions and Warnings:

    For external use only. Flammable, keep away from
    fire or flame.  Keep out of reach of
    children.  Store at 20 to 25ºC.  May
    discolor some fabrics.
  • DIRECTIONS:

    Apply to hands and rub in thoroughly until dry.
  • INACTIVE INGREDIENTS:

    Water, Coco Glycerides*, Safflower Fatty
    Acids*, Coconut Fatty Acids*, Glycerin*, Bentonite, Silicia, Vanilla*
    (Vanilla planifolia) Fruit Flavour, Peppermint* (Mentha piperita) Oil,
    Tocopherol (vitamin E), Potasium Hydroxide.
    *Certified organic
  • PRINCIPAL DISPLAY PANEL

    Master Label
  • INGREDIENTS AND APPEARANCE
    NATURALLY NOVA SCOTIA HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62.0 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59958-100-0260 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33312/10/2009
    Labeler - Owen Biosciences, Inc. (790003045)
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