Label: HAND SANITIZER- ethyl 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 January 11, 2016

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  • ACTIVE INGREDIENT

    Active ingredient:
    Ethyl alcohol, 62%

  • PURPOSE

    Purpose Antiseptic

  • WARNINGS

    Warnings:

    For external use only.

    FLAMMBLE. Keep away from fire or flame.

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply a small amount into palm of hand
    • Rub thoroughly over both hands until dry
    • Not to be rinsed off with water
    • Children must be supervised when using this product
    • For personal / domestic use
    • Do not dilute product
  • INACTIVE INGREDIENT

    Inactive ingredients: water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, acrylates copolymer, polyethylene terephthalate, red 33, diatomaceous earth.

  • STORAGE AND HANDLING

    Other Information:

    Do not store in temperatures above 118 F

  • INDICATIONS & USAGE

    Uses:

    • Hand sanitizer to help reduce bacteria on the skin.
    • Recommended for repeated use.
  • WHEN USING

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49435-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.70-1.00) (UNII: 645M2T7FHZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49435-001-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/11/2016
    Labeler - NPW-USA, Inc. (079831598)
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