Label: ANTISEPTIC HAND SANITIZER- alcohol gel

  • NDC Code(s): 63710-004-00, 63710-004-01
  • Packager: Laboratorios Zeyco, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

    Purpose

    Antiseptic

  • Use

    for hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    Flammable, keep away from fire and flame.

    Do not use

    in the eyes

    Stop use and ask a doctor if:

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other information

    Store at no more than 86ºF (30ºC)

  • Inactive ingredients

    Aminomethyl propanol, carbomer, glycerin, water.

  • Package Labeling:500ml

    Bottle

  • Package Labeling:125ml

    Bottle2

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63710-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63710-004-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    2NDC:63710-004-01125 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/02/2020
    Labeler - Laboratorios Zeyco, S.A. de C.V. (812517605)
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