SAN-X E3 (ETHANOL) LIQUID [AMERISAN, LLC]

SAN-X E3 (ETHANOL) LIQUID [AMERISAN, LLC]
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NDC 69884-703-06
Set ID 2c51618c-0625-5d19-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Amerisan, LLC
Generic Name
Product Class
Product Number
Application Number PART333E
  • 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 finalpart333E02/12/2016
    Labeler - Amerisan, LLC (170260090)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(69884-703)

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