Label: SPECTRUM- ethyl alcohol gel

  • NDC Code(s): 53329-009-02
  • 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 16, 2022

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  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeat 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
    • not recommended for infants
  • 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, aloe barbadensis leaf juice, diisopropylamine, glycerin, isopropyl myristate, tocopheryl acetate, water

  • Manufacturing Information

    Manufactored 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

    REF: HH70GPACKET

    V1 RA22VJO

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    SPECTRUM 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-009-022.4 mL in 1 PACKET; Type 0: Not a Combination Product08/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/15/2016
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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