Label: HAND SANITIZER FRAGRANCE FREE- ethyl alcohol solution

  • 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 November 21, 2022

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

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on the skin that could cause disease

    Recommended for repeated use

  • Warnings

    FLAMMABLE, keep away from fire and flame

    For external use only

  • When using this product

    do not use in or near eyes   

  • Stop use and ask a doctor

    if irritation or redness develops.  If condition persists for more than 72 hours consult a doctor.

  • Keep out of reach of children.

    If swallowed, seek immediate medical attention or call a poison control center.

  • Directions

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

  • Inactive ingredients

    Water, Isopropyl Alcohol, PEG-12 Dimethicone, Glycerin, Caprylic/Capric Triglyceride, Isopropyl Myristate

  • Additional rear label text for manual dispensers

    HighMark Manual Dispenser Foam Hand Sanitzer Refill

    Distributed by: Office Depot, LLC

    6600 N. Military Trail, Boca Raton, FL 33496 USA

    Highmark is a trademark or registered trademark of OMX, Inc.

    @2020 Office Depot, LLC.  All Rights Reserved.

    Made in USA with foreign and domestic materials

    Manufactured for Georgia-Pacific Consumer Products LP, Atlanta, GA 30303

    Questions? Call 1-877-674-0688

    Alcohol permit SDS-MO-15036  DSP-MO-28 DSP-MO-34

    33.9 FL OZ (1000 mL)

  • Additional rear label text for automatic dispensers

    HighMark Automatic Dispenser Foam Hand Sanitzer Refill

    Distributed by: Office Depot, LLC

    6600 N. Military Trail, Boca Raton, FL 33496 USA

    Highmark is a trademark or registered trademark of OMX, Inc.

    @2020 Office Depot, LLC. All Rights Reserved.

    Made in USA with foreign and domestic materials

    Manufactured for Georgia-Pacific Consumer Products LP, Atlanta, GA 30303

    Questions? Call 1-877-674-0688

    Alcohol permit SDS-MO-15036 DSP-MO-28 DSP-MO-34

    33.9 FL OZ (1000 mL)

  • principal display panel

    MANUAL DISPENSER REFILL

    FOAM HAND SANITIZER

    FRAGRANCE FREE

    33.9 fl oz (1000 mL)

    image description

  • principal display panel

    AUTOMATED DISPENSER REFILL

    FOAM HAND SANITIZER

    FRAGRANCE FREE

    33.9 FL OZ (1000 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  FRAGRANCE FREE
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61139-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61139-701-861000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2016
    Labeler - Office Max (009073099)
    Registrant - Vi-Jon, LLC. (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC.790752542manufacture(61139-701)