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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  • Active ingredient

    Benzalkonium Chloride 0.12%

  • Purpose

    Antiseptic

  • Uses

    • handwash to help reduce bacteria that potentially can cause disease
    • helps to prevent cross-contamination by hand contact
    • helps to prevent drying of the skin
    • recommended for repeated use
  • Warnings

    For external use only

    When using this product do not use in or near eyes.

    Stop use and consult a doctor if irritation and redness develop.

    Keep out of reach of children.

    If swallowed, seek medical attention or contact a Poison Control Center immediately.

  • Directions

    • wet hands and wrists with clean, running water
    • apply appropriate amount of product
    • lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds
    • rinse thoroughly with running water
    • dry hands completely (incomplete drying may result in chapped skin)
  • Other information

    store in a cool, dry place below 104 F (40 C)

  • Inactive ingredients

    Water, cocamidopropyl betaine, glycerine, polyethylene-polypropylene glycol, benzyl alcohol, phenoxyethanol, tetra sodium EDTA, dehydroacetic acid, sodium hydroxide, citric acid

  • Questions?

    Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4pm PST

  • PRINCIPAL DISPLAY PANEL

    SAN X

    E2

    Sanitizing

    Foam

    Soap

    • 0.12% Benzalkonium Chloride

    (BZK) formula

    • Formulated with emollients

    to help keep skin soft

    • Fragrance and Dye Free
    • Kosher, Pareve and Halal certified

    NSF

    Nonfood Compounds

    Program Listed (E2)

    Registration #

    AMERISAN

    Net Contents: 1250 mL (42.27 fl. oz)

    container label

  • INGREDIENTS AND APPEARANCE
    SAN X E2 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69884-706
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69884-706-061250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/31/2022
    Labeler - Amerisan, LLC (170260090)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers627278224manufacture(69884-706)
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