drug facts

drug facts
SPL v2
SPL
SPL Set ID 14ba88a3-af32-4191-afed-cdcc7eb8ad6a
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 hydroxyethyl cellulose (4000 mpa.s at 1%) cocamidopropyl pg-dimonium chloride phosphate phenoxyethanol myristic diisopropanolamide myristamine oxide methyl gluceth-20 glyceryl mono- and dicaprylocaprate alcohol peg-12 dimethicone (300 cst) anhydrous citric acid polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) potassium hydroxide fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-09-06

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 product
  • 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, hydroxyethylcellulose, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, myristamide DIPA, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, citric acid, polyquatemium-7, fragrance, potassium hydroxide, blue 1

Section 53413-1

Questions? call 1-866-781-8787

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

KEYSTONE  Sysco

ADVANCED ANTIBACTERIAL LIQUID HAND SOAP

Active Ingredient: 0.5% Benzalkonium Chloride

Net Contents

750 mL (25 US fl oz) 6000234

Sysco 5287436      6101969 ECOLAB®

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

For SDS information visit: www.cleanwithkeystone.com

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)

© 2018 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.ecolab.com · 773734/5400/0818


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 product
  • 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, hydroxyethylcellulose, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, myristamide DIPA, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, citric acid, polyquatemium-7, fragrance, potassium hydroxide, blue 1

Section 53413-1 (53413-1)

Questions? call 1-866-781-8787

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

KEYSTONE  Sysco

ADVANCED ANTIBACTERIAL LIQUID HAND SOAP

Active Ingredient: 0.5% Benzalkonium Chloride

Net Contents

750 mL (25 US fl oz) 6000234

Sysco 5287436      6101969 ECOLAB®

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

For SDS information visit: www.cleanwithkeystone.com

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)

© 2018 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.ecolab.com · 773734/5400/0818


Advanced Ingredient Data


Raw Label Data

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