Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 78495-002-01
  • Packager: Ultra Distributors Inc
  • 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 4, 2020

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  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only: hands

    Flammable. Keep away from fire 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.
    • do not inhale or ingest.
  • STOP USE

    Stop use and ask a doctor if

    • irritation or redness develops.
    • condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center(1-800-222-1222)right away.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping.
    • for children under 6 , use only under adult supervision.
    • not recommended for infants .

  • Other information

    • do not store above 105°F
    • may discolor some fabics
    • harmful to wood finished and plastics
  • Inactive ingredients

    water, glycerin, propylene glycol, acrylates/C10-C30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf juice, maltodextrin

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78495-002
    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
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78495-002-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/04/2020
    Labeler - Ultra Distributors Inc (007160073)
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