Label: INSTANT HAND SANITIZER- alcohol spray

  • 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 September 29, 2020

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  • Drug Facts

  • Active ingredient:

    Ethyl Alcohol 68%

    Purpose:

    Antiseptic

  • Uses:

    • Hand sanitizer reduce bacteria on skin
  • Warnings:

    Flammable, Keep away from fire and flame.

    For external use only

    When using this product:

    do not use in or near eyes, in case of contact, rinse eyes thoroughly with water.

    Keep out of reach of children

  • Directions:

    Place product on hands, rub untill dry

  • Ingreidients:

    Glycerin, propylene glycol, triethanolamine, carbomer, fragrance, disodium edta,tocopheryl acetate, deionized water.

  • Package Labeling:

    Bottle7

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80575-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.68 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80575-003-0120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2020
    Labeler - National Design LLC (360763320)
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