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
  • 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 August 9, 2023

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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 not finalpart333E07/06/2018
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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