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 March 9, 2022

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  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin
    • 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

    • wet hands thoroughly with product
    • allow to dry without wiping
    • children under 6 should be supervised while using this product
  • Inactive ingredients

    aloe vera, carbomer, purified water, triethanolamine

  • Principal Display Panel - 59 mL Bottle Label

    NDC 25113-444-16

    Dodge

    quiksan®

    Instant
    Hand
    Santizer

    MEETS CDC HANDWASHING RECOMMENDATIONS

    Kills 99.9% of Germs

    Enriched with Aloe Vera

    Unscented

    2 fl oz (59mL)

    Made in U.S.A.

    Principal Display Panel - 59 mL 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 vera leaf (UNII: ZY81Z83H0X)  
    carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25113-444-160.059 L in 1 BOTTLE; Type 0: Not a Combination Product03/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/18/2022
    Labeler - Dodge (001045517)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(25113-444)
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