Label: HAND SANITIZER- 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 September 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use(s)

    Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    For external use only. Flammable. Keep away from fire and flame.

    When using this product do not use in or near the eyes. In case of contact with eyes, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

  • Directions

    • Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.
    • Supervise children under 6 years of age when using this product.
  • Other Information

    • Store below 110 F (43 C)
    • May discolor certain fabrics or surfaces
  • Inactive Ingredients

    USP water, propan-2-ol, glycerin, fragrance, acrylates c10-30 aklyl acrylate crosspolymer, aminomethyl propanol

  • SPL UNCLASSIFIED SECTION

    Distributed by Nine Mile Health, LLC
    5500 Greenwood Plaza Blvd.
    Suite 130, Greenwood Village, CO 80111

  • Questions?

    www.ninemilehealth.com ▪ (833) 665-3300

  • PRINCIPAL DISPLAY PANEL - 128 fl oz Bottle Label

    KILLS >99.9%
    OF COMMON GERMS
    IN 15 SECONDS!

    NINE MILE
    HEALTH

    GEL

    HAND SANITIZER 70%

    The hand sanitizing gel crafted with naturally
    derived ingredients specifically for your hands.

    1 GALLON
    (128 fl oz)

    Principal Display Panel - 128 fl oz Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78697-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78697-070-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A08/01/2020
    Labeler - Nine Mile Health, LLC (131106596)
    Establishment
    NameAddressID/FEIBusiness Operations
    Economy Polymers008087603MANUFACTURE(78697-070)
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