Label: SMART SAN HAND SANITIZER- ethanol liquid

  • Category: HUMAN OTC DRUG LABEL

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 April 25, 2010

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  • Active Ingredient

    Ethanol 64%

  • Purpose

    Hand Sanitizer

  • Uses

    • Sanitize hand 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

    • 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
    • Discontinue use if irritation and redness develop
  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directions

    • Cover hands thoroughly with gel, covering entire surface of hands, especially the fingernails and cuticles
    • Rub hands together until dry
  • Other Information

    • Store in a cool dry place below 104° F
  • Inactive ingredients

    purified water, carbopol, glycerin, glycereth-2-cocate, triethanolamine

  • Questions?

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

  • Principal Display Panel

    NDC 59900-116-01

    NDC 59900-116-02

    NDC 59900-116-03

    NDC 59900-116-04

    NDC 59900-116-06

    Smart San™ hand Sanitizer Gel

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SMART SAN HAND SANITIZER 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ethanol (UNII: 3K9958V90M) (Ethanol - UNII:3K9958V90M) Ethanol693 g  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59900-116-061250 mL in 1 BOTTLE, PLASTIC
    2NDC:59900-116-0459 mL in 1 BOTTLE, PLASTIC
    3NDC:59900-116-03907.1 mL in 1 BOTTLE, PLASTIC
    4NDC:59900-116-011000 mL in 1 BOTTLE, PLASTIC
    5NDC:59900-116-022000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2001
    Labeler - Best Sanitizers, Inc (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc627278224manufacture
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