Label: SATSUMA- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 12, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Alcohol 73.4%

  • Purpose

    Antiseptic hand wash

  • Uses

    • Hand washing to decrease bacteria on the skin. Recommended for repeated use.
  • Warnings

    • Flammable, keep away from fire or flame.
    • For external use only.

    When using this product

    • Do not use in the eyes.
    • Do not use on broken skin.

    • Stop use and ask a doctor if irritation and redness develop or condition persists for more than 72 hours.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 should be supervised when using this product.
  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
  • Inactive ingredients

    Water, Betaine, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-40 Hydrogenated Castor Oil, Aminomethyl Propanol, Limonene, Fragrance, t-Butyl Alcohol, Hexyl Cinnamal, Citrus Unshiu Fruit Extract, Citral, Citrus Aurantium Dulcis (Orange) Oil, Disodium EDTA, Anthemis Nobilis Flower Extract, Linalool, Citrus Unshiu Fruit Oil, Denatonium Benzoate.

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    THE
    BODY
    SHOP    ®

    SATSUMA
    ANTIBACTERIAL
    HAND SANITIZER
    Kills 99.9% of germs. NO TRICLOSAN

    60 mL (2.0 US FL OZ)

    Principal Display Panel - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SATSUMA   ANTIBACTERIAL HAND SANITIZER
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-564
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol0.734 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Betaine (UNII: 3SCV180C9W)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)  
    AminomethylPropanol (UNII: LU49E6626Q)  
    .alpha.-hexylcinnamaldehyde (UNII: 7X6O37OK2I)  
    Tangerine (UNII: KH3E3096OO)  
    Citral (UNII: T7EU0O9VPP)  
    Orange Oil (UNII: AKN3KSD11B)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
    Linalool, DL- (UNII: D81QY6I88E)  
    Denatonium Benzoate (UNII: 4YK5Z54AT2)  
    Product Characteristics
    ColorYELLOW (Colourless to pale yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57691-564-6060 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E09/15/2010
    Labeler - The Body Shop Wake Forest (791071279)
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