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 February 10, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • to help decrease bacteria on the skin when water, soap & towel are not available.
    • recommended for repeated use
  • Warnings

    For external use only

    Flammable, keep away from fire or flame

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

    Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

    Keep out of reach of children

    If ingested get medical help or contact a Poison Control Center right away

  • Directions

    • apply small amount to dry hands
    • rub hands together coating entire surface of hands
    • QuikSan will disappear in about 15 seconds
  • Inactive ingredients

    aloe vera, carbomer, purified water, triethanolamine

  • Principal Display Panel - 1.5 fl oz Bottle Label

    NDC 25113-444-15

    quiksan®

    Instant Hand Sanitizer

    MEETS CDC HANDWASHING RECOMMENDATIONS

    Kills 99.9% of Germs

    Enriched with Aloe Vera

    Unscented

    1.5 fl oz (44.3 mL)

    Principal Display Panel - 1.5 fl oz Bottle Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25113-444
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mg  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:25113-444-150.0443 L in 1 BOTTLE; Type 0: Not a Combination Product02/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/03/2015
    Labeler - Dodge (001045517)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(25113-444)
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