Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID b742f102-a60c-4ed0-8d6c-d6721c9ec5dc
Route
TOPICAL
Published
Effective Date 2024-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 mg)
Inactive Ingredients
Water Isopropyl Alcohol Propylene Glycol Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-07-26

Description

Benzalkonium chloride 0.1%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.1%

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

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

Section 51727-6

Inactive ingredients  water (aqua), isopropyl alcohol, propylene glycol, red 40, blue 1

Warnings
For external use only

Directions
  • wash hands to remove soil
  • dispense 20 mL into hand (palmful)
  • spread to cover hands, rub in well for at least 30 seconds
  • air dry, do not rinse or towel dry
Do Not Use
  • in eyes
Questions?

call 1-800-35-CLEAN (352-5326)

Active Ingredient

Benzalkonium chloride 0.1%

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
  • discontinue use if irritation and redness develop
Stop Use and Ask A Doctor If

irritation and redness develop

Primary Display Panel / Representative Label

KEYSTONE    SYSCO

FOAM HAND SANITIZER

Active Ingredient: Benzalkonium chloride 0.1%

Sysco 7715473 6100098 ECOLAB

750 ML (25 US FL OZ)

Distributed by

Sysco Corporation

Manufactured by:

Ecolab - 1 Ecolab Place - St. Paul MN 55102

tel: 1 800 35 CLEAN (352 5326)

(c) 2021 Ecolab USA Inc - All rights reserved

Made in U.S.A.


Structured Label Content

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

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

Section 51727-6 (51727-6)

Inactive ingredients  water (aqua), isopropyl alcohol, propylene glycol, red 40, blue 1

Purpose

Antiseptic handwash

Warnings
For external use only

Directions
  • wash hands to remove soil
  • dispense 20 mL into hand (palmful)
  • spread to cover hands, rub in well for at least 30 seconds
  • air dry, do not rinse or towel dry
Do Not Use (Do not use)
  • in eyes
Questions?

call 1-800-35-CLEAN (352-5326)

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.1%

Other Information (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)
  • discontinue use if irritation and redness develop
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation and redness develop

Primary Display Panel / Representative Label (Primary Display Panel / Representative label)

KEYSTONE    SYSCO

FOAM HAND SANITIZER

Active Ingredient: Benzalkonium chloride 0.1%

Sysco 7715473 6100098 ECOLAB

750 ML (25 US FL OZ)

Distributed by

Sysco Corporation

Manufactured by:

Ecolab - 1 Ecolab Place - St. Paul MN 55102

tel: 1 800 35 CLEAN (352 5326)

(c) 2021 Ecolab USA Inc - All rights reserved

Made in U.S.A.


Advanced Ingredient Data


Raw Label Data

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