Label: SPECTRUM 62% HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 53329-214-13, 53329-214-70, 53329-214-84, 53329-214-85
  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Ethyl alcohol 62% v/v

  • 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 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 onlyunder adult supervision
    • not recommended for infants
  • Other information

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

    aloe barbadensis leaf juice, carbomer, diisopropylamine, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, 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: HH62G1000

    V2 RH22VJO

  • Package Label

    Label V2 RH22VJO

  • INGREDIENTS AND APPEARANCE
    SPECTRUM 62% HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-214
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-214-1359.147 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/201812/06/2022
    2NDC:53329-214-70443.6 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/201801/31/2022
    3NDC:53329-214-841000 mL in 1 BAG; Type 0: Not a Combination Product04/09/2018
    4NDC:53329-214-85354 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/09/2018
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!