Label: DIGISAN- 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 July 19, 2023

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  • Active Ingredient

    Ethyl alcohol, 54.7% w/w

    (equivalent to 62.5% v/v )

  • Purpose

    Antiseptic handwash

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warnings

    For external use only
    Flammable, keep away from fire or flame, heat sparks, and sources of static discharge 
    Contents under pressure.  Do not store at temperatures above 120 oF (48 oC), puncture or incinerate
    Operate only with spout pointing down 

    Do not use

    • in eyes

    When using this product

    • If in eyes, rinse promptly and thoroughly with water
    • discontinue use if irritation and redness develop

    Stop use and ask a doctor if skin irritation or redness occurs 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

    • spread thoroughly onto hands and rub until dry
  • Other information

    • For additional information, see Safety Data Sheet (SDS)
    • For emergency medical information in USA and Canada, call 1-800-328-0026
    • For emergency medical information worldwide, call 1-651-222-5352 (in the USA)
  • Inactive ingredients

    water (aqua), isobutane, glycerin, cetearyl alcohol, hydrofluorocarbon 152A, propane, polysorbate-60, sodium lauroyl lactylate, steareth-20, sodium benzoate, tert-butyl alcohol, dentatonium benzoate

  • QUESTIONS

    Questions? Call 1-800-35-CLEAN (352-5326)

  • Principal display panel and representative label

    ECOLAB

    6124832

    DigiSan™ Aerosol Foam Hand Sanitizer

    Active Ingredient: Ethyl alcohol 54.7 w/w (eqiuvalent to 62.5% v/v)

    198 G (7 OZ)

    This product may be patented: www.ecolab.com/patents

    SDS-MA-1396

    Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA ·

    tel: 1 800 35 CLEAN (352 5326)

    © 2019 Ecolab USA Inc · All rights reserved

    Made in U.S.A.

    www.ecolab.com · 749270/5402/0219

    representative label

  • INGREDIENTS AND APPEARANCE
    DIGISAN  
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-617
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.547 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOBUTANE (UNII: BXR49TP611)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    PROPANE (UNII: T75W9911L6)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-617-82198000 mg in 1 CAN; Type 0: Not a Combination Product01/10/200101/25/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/10/200101/25/2025
    Labeler - Ecolab Inc. (006154611)
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