UNSCENTED (HAND SANITIZER) LIQUID [SANTE MANUFACTURING INC]

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UNSCENTED (HAND SANITIZER) LIQUID [SANTE MANUFACTURING INC]
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NDC 71020-013-16
Set ID 4a6fee31-dd6e-6ad6-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Sante Manufacturing Inc
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active Ingredients - Ethyl Alcohol 70%

  • PURPOSE

    Purpose - Antiseptic

  • INDICATIONS & USAGE

    Use hand sanitizer to help reduce disease causing bacteria on the skin

  • WARNINGS

    Warnings

    Flammable

  • OTHER SAFETY INFORMATION

    Keep away from fire or flame

  • WHEN USING

    Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or rdeness develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally to hands and rub thoroughly until dry
    • supervise children in the use of this product
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Carbomer, Triethanolamine, Glycerin, Propylene Glycol, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    Spasoap

    Extra Strength with moisturizers & Vitamin E

    Hand Sanitizer

    Kills 99% of germs

    Unscented

    ​16oz / 500ml Unscented

  • INGREDIENTS AND APPEARANCE
    UNSCENTED 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71020-013-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/11/2017
    Labeler - Sante Manufacturing Inc (242048747)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sante Manufacturing Inc242048747manufacture(71020-013)
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