Label: SPECTRUM HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 53329-003-14, 53329-003-70, 53329-003-74, 53329-003-84
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 29, 2024

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  • Active ingredient

    Ethyl alcohol 85% v/v

  • Purpose

    Antiseptic

  • Uses

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

    For external use only.

    Flammable. Keep away from heat and 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 and ask a doctor if

    • irritation or redness develops
    • 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
    • for children under 6, use only under adult supervision
  • Other information

    • do not store above 105ºF
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, myristyl alcohol, povidone, tetrahydroxypropyl ethylenediamine, water

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with US and Foreign components

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: HH851200G

    V2 RB23VJO

  • Package Label

    Front Label V2 RB23VJO

    Back Label V2 RB23VJO

  • INGREDIENTS AND APPEARANCE
    SPECTRUM HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE (UNII: FZ989GH94E)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-003-1459 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/201804/30/2023
    2NDC:53329-003-70443 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/201809/30/2020
    3NDC:53329-003-841000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/201802/17/2023
    4NDC:53329-003-741200 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/06/2018
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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