Label: ANTIBACTERIAL HAND SANITIZER- alcohol spray

  • 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 September 22, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 68%

    Purpose

    Antiseptic

  • Uses

    • For hand sanitizing
  • Warnings

    For external use only hands.

    Flammable. Keep away from heat or flame.

    When using this product

    Keep out of eyes.  In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

    Keep out of reach of children

  • Other information:

    store at 20°C (68° to 77° F). may discolor fabrics.

  • Ingreidients:

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

  • Package Labeling:

    BottleLabel

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80575-000
    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:80575-000-0110 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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