drug facts

drug facts
SPL v3
SPL
SPL Set ID e624ea46-e502-4d2d-aaa1-59954f69be05
Route
topical
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-07-26

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.5%


Medication Information

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
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1 800 328 0026
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, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1

Section 53413-1

Questions? call 1-866-444-7450

Warning
For external use only
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 and Representative Label

Advanced Antibacterial Foaming Hand Soap

Hand Care

Active ingredient: Benzalkonium Chloride 0.5%

Product No.

8000329

42.3 US FL OZ

(1250 mL)

766424/5401/1020

Distributed by

Ecolab

1 Ecolab Place

St. Paul MN 55102 USA

© 2020 Ecolab USA Inc

All rights reserved

Made in U.S.A.

www.ecolab.com


Structured Label Content

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)
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1 800 328 0026
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, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1

Section 53413-1 (53413-1)

Questions? call 1-866-444-7450

Warning
For external use only
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 and Representative Label (Principal display panel and representative label)

Advanced Antibacterial Foaming Hand Soap

Hand Care

Active ingredient: Benzalkonium Chloride 0.5%

Product No.

8000329

42.3 US FL OZ

(1250 mL)

766424/5401/1020

Distributed by

Ecolab

1 Ecolab Place

St. Paul MN 55102 USA

© 2020 Ecolab USA Inc

All rights reserved

Made in U.S.A.

www.ecolab.com


Advanced Ingredient Data


Raw Label Data

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