Label: INSTANT HAND SANITIZER- alcohol gel

  • 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 November 21, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on skin without soap and water.

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Keep out of reach of children.

    Do not use in eyes, if this happens, rinse thoroughly with water.

    Stop use, ask a doctor If irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hands & wrists thoroughly with product and allow to dry without wiping
  • Inactive ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

  • PRINCIPAL DISPLAY PANEL – Sanear 0.057 fl. oz. Pouch

    SaniPortables®

    Instant Hand

    Sanitizer

    KILLS 99.9% of GERMS

    FRESH SCENT

    Enriched with Aloe Vera

    0.057 fl. oz. (1.68 ML)

    Distributed by

    SANEAR Corporation

    Matthews, NC 28105

    PRINCIPAL DISPLAY PANEL – Sanear 0.057 fl. oz. Pouch
  • PRINCIPAL DISPLAY PANEL – Sanear 25 count Box

    Made in the U.S.A.

    NDC 23638-1111-1

    SaniPortables®

    Instant Hand Sanitizer

    KILLS 99.9% of GERMS

    Fresh Scent

    Enriched with Aloe Vera

    25 packets

    Each Packet .057 fl. oz. (1.68 ML)

    PRINCIPAL DISPLAY PANEL – Sanear 25 count Box
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23638-1111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    aloe (UNII: V5VD430YW9)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23638-1111-125 in 1 BOX
    10.00168 L in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/21/2011
    Labeler - Sanear Corporation (831894980)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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