Label: SAN-X E3- ethanol liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 31, 2022

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethanol 62%

  • PURPOSE

    Purpose

    Hand Sanitizer

  • INDICATIONS & USAGE

    Uses

    • Sanitizes hands to help reduce bacteria that potentially can cause diseases
    • Helps to prevent cross contamination
    • Helps to prevent drying of the skin
    • Recommended for repeated use

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Receive a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together until dry
  • STORAGE AND HANDLING

    Other information

    • Store in a cool, dry place below 104°F
  • INACTIVE INGREDIENT

    Inactive ingredients

    DEA-C8-18 perfluoroalkylethylphosphate, glycereth-2 cocoate, denatonium benzoate, tert-butyl alcohol, water

  • QUESTIONS

    Questions?

    Contact Amerisan, Mon-Fri

    9am - 4pm EDT at 888-586-7990

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Amerisan, LLC.

    1833 Columbia Ave., Folcroft, PA 19032

  • SAN-X E3

    Hand Sanitizer Foam

    • Engineered to meet the tough requirements of the food industry
    • Kills 99.999% of tested pathogens in 15 seconds

    AMERISAN

    WWW.AMERISAN.COM

    WWW.AMERISANUSA.COM

    Net Contents: 1250 mL (42.27 fl. oz.)

    Fits Dispensers

    Manual E713

    Auto E710

  • PRINCIPAL DISPLAY PANEL

    Amerisan 703-06

  • INGREDIENTS AND APPEARANCE
    SAN-X E3 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69884-703
    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
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    WATER (UNII: 059QF0KO0R)  
    DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69884-703-061250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/12/201611/30/2024
    Labeler - Amerisan, LLC (170260090)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(69884-703)
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