Label: SMART SAN HAND SANITIZER FRAGRANCE-FREE- alcohol liquid

  • NDC Code(s): 59900-126-04, 59900-126-07, 59900-126-10
  • 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 1, 2019

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl alcohol 71.0%

  • PURPOSE

    Purpose

    Hand Sanitizer

  • INDICATIONS & USAGE

    Uses

    • sanitizes 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
    • Flammable, keep away from fire or flame

    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

    • wet hands thoroughly with spray, covering entire surface of hands, especially the fingernails and cuticles
    • rub hands together until dry
  • STORAGE AND HANDLING

    Other information

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

  • INACTIVE INGREDIENT

    Inactive ingredents

    Water, Isopropanol, glycerin, glycerol monolaurate

  • QUESTIONS

    Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Smart

    San

    hand sanitizer spray

    with natural emollients

    to soften hands

    kills 99.9999% of

    26 tested pathogens

    fragrance-free

    Net Contents:

    container label

  • INGREDIENTS AND APPEARANCE
    SMART SAN HAND SANITIZER FRAGRANCE-FREE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59900-126-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    2NDC:59900-126-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    3NDC:59900-126-1059 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2019
    Labeler - Best Sanitizers, Inc. (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc.627278224manufacture(59900-126)
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