Label: HAND SANITIZER- ethyl alcohol liquid

  • 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 December 31, 2018

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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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