Label: SAN-X E2- benzalkonium chloride 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 January 31, 2022

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.12%

  • PURPOSE

    Purpose

    Antiseptic Hand Cleanser

  • INDICATIONS & USAGE

    Uses

    • Hand wash 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
  • WHEN USING

    When using this product

    • Do not use in or near the eyes
  • 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

    • Wet hands and forearms
    • Apply appropriate amount to hands, wrists and forearms
    • Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
    • Rinse with water
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    Benzyl alcohol, cocoamidopropyl betaine, dehydroacetic acid, glycerine, phenoxyethanol, polyethylene-polypropylene glycol, tetra sodium EDTA, water

  • QUESTIONS

    Questions?

    Contact Amerisan, Mon-Fri

    9am - 4pm EDT at 888-586-7660

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Amerisan, LLC.

    1833 Columbia Ave., Folcroft, PA 19032

  • PRINCIPAL DISPLAY PANEL

    SAN-X E2

    Sanitizing Foam Soap

    • 0.12% Benzalkonium Chloride (BZK) formula
    • pH balanced
    • Formulated with emollients to help keep skin soft

    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 707-06

  • INGREDIENTS AND APPEARANCE
    SAN-X E2 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69884-707
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETIC ACID (UNII: 9G34HU7RV0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69884-707-061250 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 finalpart333E02/19/201612/31/2024
    Labeler - Amerisan, LLC (170260090)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(69884-707)
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