drug facts

drug facts
SPL v3
SPL
SPL Set ID 04e2f617-0643-4097-8780-b64c58c5b56c
Route
topical
Published
Effective Date 2024-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (5 mg)
Inactive Ingredients
water cocamine oxide hexylene glycol polyethylene glycol 8000 glycerin cocamidopropyl propylene glycol-dimonium chloride phosphate phenoxyethanol polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) myristic diisopropanolamide myristamine oxide anhydrous citric acid methyl gluceth-20 glyceryl mono- and dicaprylocaprate alcohol peg-12 dimethicone (300 cst) potassium citrate fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-06-20

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.5%


Medication Information

Warnings
For external use only
Uses
  • for handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinse thoroughly and dry
Other Information
  • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT
  • EMERGENCY HEALTH INFORMATIN: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
Description

Benzalkonium chloride 0.5%

Section 50565-1

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

Section 50569-3

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Section 51727-6

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, polyquaternium-7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1

Section 53413-1

Questions? call 1.866.444.7450

Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

When Using the Product
  • if in eyes, rinse promptly and thoroughly with water 
  • discontinue use if irritation and redness develop
Principal Display Panel & Representative Package

SWISHER

HIGH PERFORMANCE ANTIBACTERIAL HAND SOAP

6101901

750 mL (25 US FL OZ)

Active ingredient:

Benzalkonium chloride 0.5%

772409/5401/0521

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

© 2021 Ecolab USA Inc. · All rights reserved

Made in U.S.A.


Structured Label Content

Warnings
For external use only
Uses
  • for handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinse thoroughly and dry
Other Information (Other information)
  • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT
  • EMERGENCY HEALTH INFORMATIN: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
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 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Section 51727-6 (51727-6)

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, polyquaternium-7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1

Section 53413-1 (53413-1)

Questions? call 1.866.444.7450

Do Not Use (Do not use)
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

When Using the Product (When using the product)
  • if in eyes, rinse promptly and thoroughly with water 
  • discontinue use if irritation and redness develop
Principal Display Panel & Representative Package (Principal display panel & representative package)

SWISHER

HIGH PERFORMANCE ANTIBACTERIAL HAND SOAP

6101901

750 mL (25 US FL OZ)

Active ingredient:

Benzalkonium chloride 0.5%

772409/5401/0521

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

© 2021 Ecolab USA Inc. · All rights reserved

Made in U.S.A.


Advanced Ingredient Data


Raw Label Data

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