Label: SMART SAN ALCOHOL-FREE HAND SANITIZER FOAM- benzalkonium chloride liquid

  • NDC Code(s): 59900-119-05, 59900-119-08, 59900-119-10
  • Packager: Best Sanitizers, Inc.
  • 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 May 10, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.12% w/w

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • sanitize hands to help reduce bacteria that potentially can cause disease
    • helps to prevent cross-contamination
    • recommended for repeated use
    • helps prevent drying of skin
  • WARNINGS

    Warnings

    • For external use only

    When using this product

    • do not use in or near eyes
    • use in a well-ventilated area
    • for external use only

    Stop use and ask a doctor if irritation or redness develop.

    Keep out of reach of children.

    If swallowed, seek medical attention or contact 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 104o F (40o C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, cocamidopropyl betaine, glycerin, poloxamer 124, phenoxyethanol, benzyl alcohol, dehydroacetic acid, sodium hydroxide, citric acid

  • QUESTIONS

    Questions?

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

  • PRINCIPAL DISPLAY PANEL

    versaclenz compatible

    Smart San

    alcohol-free

    hand sanitizer

    foam

    with natural

    emollients to

    soften hands

    kills 99.9%-99.999%

    of tested pathogens

    Net Contents:

    container label

  • INGREDIENTS AND APPEARANCE
    SMART SAN ALCOHOL-FREE HAND SANITIZER FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59900-119-051250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2019
    2NDC:59900-119-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2019
    3NDC:59900-119-1059 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/10/2019
    Labeler - Best Sanitizers, Inc. (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc.627278224manufacture(59900-119)