Label: FRAIS HAND SANITIZER- 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 2, 2009

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  • ACTIVE INGREDIENT

    Ethyl alcohol (66%)

  • USE

    For hand washing to decrease bacteria on the skin.

  • WARNINGS

    Do not ingest.  Do not use in eyes.  Supervise children’s use.  Flammable.

  • DIRECTIONS

    Place a dollop into hands without water. Rub together until dry.

  • OTHER INFORMATION

    Keep away from fire or flame. Store at normal room temperature. Avoid freezing conditions.

  • INACTIVE INGREDIENTS

    Aqua, Citrus Aurantium Dulcis Peel Oil, Melaleuca Quinquenervia Oil, Citrus Grandis Peel Oil, Backhousia Citriodora Leaf Oil, Ocimum Basilicum Oil, Citrus Tangerina Peel Oil, Elettaria Cardamomum Seed Oil, Zingiber Officinale Root Oil, Methylcellulose

  • INFORMATION FOR PATIENTS

    Not tested on animals.  Made in China from Australian blended essential oils and local ingredients.  Recyclable.

  • HOW SUPPLIED


    FRAIS LUXURY PRODUCTS PTY LTD
    4/59 Bream St, Coogee NSW 2034 Australia.
    Los Angeles, USA    London, UK
    www.frais.com.au
  • PRINCIPAL DISPLAY PANEL

    444ml Product Label
    Frais™


    HAND SANITIZER

    Les Huit

    WITH GINGER, TANGERINE,

    LEMON MYRTLE, NIAOULI, ORANGE,

    BASIL, GRAPEFRUIT AND CARDAMOM

    KILLS 99.9% OF GERMS

    66% Sugarcane Alcohol.  ℮ 444ml (15fl. oz.)

  • INGREDIENTS AND APPEARANCE
    FRAIS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42587-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J) 1 g  in 100 g
    WATER (UNII: 059QF0KO0R) 32 g  in 100 g
    VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)  
    ORANGE (UNII: 5EVU04N5QU)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    TANGERINE (UNII: KH3E3096OO)  
    CARDAMOM (UNII: 8BC4CUT4JL)  
    MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E)  
    BASIL (UNII: 2U0KZP0FDW)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42587-001-016 g in 1 BOTTLE, PLASTIC
    2NDC:42587-001-0250 g in 1 BOTTLE, PLASTIC
    3NDC:42587-001-03444 g in 1 BOTTLE, PUMP
    4NDC:42587-001-0414 in 1 BOX
    4NDC:42587-001-016 g in 1 BOTTLE, PLASTIC
    5NDC:42587-001-051 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/15/2008
    Labeler - Frais Luxury Products (832784354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Frais Luxury Products Pty Ltd755387342manufacture
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