Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID aa921967-cd15-4bc2-9452-763746274702
Route
TOPICAL
Published
Effective Date 2025-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.547 mg)
Inactive Ingredients
Water Isobutane Glycerin Cetostearyl Alcohol 1,1-difluoroethane Propane Polysorbate 60 Sodium Lauroyl Lactylate Steareth-20 Sodium Benzoate Tert-butyl Alcohol Denatonium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2003-10-31 Until 2027-06-30

Description

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

Purpose

Antiseptic Handwash


Medication Information

Purpose

Antiseptic Handwash

Description

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

Uses
  • for handwashing to decrease bacteria on the skin
Section 50565-1

Keep out of reach children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

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

Section 53413-1

Questions?   call  1-800-35-CLEAN (352-5326).

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 o F (48 o C), puncture or incinerate

Operate only with spout pointing down

Directions
  • spread thoroughly onto hands and rub until dry.
Do Not Use
  • in eyes
Active Ingredient

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

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)
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 Physician If
  • skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

ECOLAB

6122644

DigiSan™ Healthcare Hand

Sanitizer F oam

425 G (15 OZ)

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

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 · 720162/5403/0219


Structured Label Content

Uses
  • for handwashing to decrease bacteria on the skin
Section 50565-1 (50565-1)

Keep out of reach children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions?   call  1-800-35-CLEAN (352-5326).

Purpose

Antiseptic Handwash

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 o F (48 o C), puncture or incinerate

Operate only with spout pointing down

Directions
  • spread thoroughly onto hands and rub until dry.
Do Not Use (Do not use)
  • in eyes
Active Ingredient (Active ingredient)

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

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)
When Using This Product (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 Physician If (Stop use and ask a physician if)
  • skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label (Principal display panel and representative label)

ECOLAB

6122644

DigiSan™ Healthcare Hand

Sanitizer F oam

425 G (15 OZ)

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

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 · 720162/5403/0219


Advanced Ingredient Data


Raw Label Data

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