HAND SANITIZER (ETHYL ALCOHOL) LIQUID [SIMONIZ USA, INC.]

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HAND SANITIZER (ETHYL ALCOHOL) LIQUID [SIMONIZ USA, INC.]
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NDC 63900-130-04
Set ID 1eda55f3-612e-69ec-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Simoniz USA, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

    Hand Sanitizer

  • Uses

    • For hand sanitizing to decrease bacteria on the skin.
    • Recommended for repeated use
  • Warnings

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

    When using this product

    • Do not use in or near eyes
    • Use in a well-ventilated area
    • Discontinue use if irritation and redness develop
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directions

    • Dispense a small amount of gel into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together until dry
  • Other information

    • Store in a cool dry place below 104°F
  • Inactive ingredients

    DEA-C8-18 perfluoroalkylethyl phosphate, Glycereth-2 cocoate, Water, Denatoniom Benzoate, Tert-Butyl Alcohol

  • QUESTIONS

    Questions?

    Contact Simoniz Mon-Fri 8am-5pm EST at 1-800-227-5536

    Bolton, CT 06043

  • SaniCheck

    HAND SANITIZER

    Antiseptic Foam

    Kills 99.999% of most Germs Without Water

    Hospital Approved

    250 mL - (8.45 fl oz)

  • PRINCIPAL DISPLAY PANEL

    Sanicheck Foam FrontSanicheck Foam Back

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63900-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63900-130-04250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/03/2015
    Labeler - Simoniz USA, Inc. (058510272)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(63900-130)
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