Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 68e3174e-cb96-4739-a723-c36b2389f4f6
Route
TOPICAL
Published
Effective Date 2024-08-02
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 2017-12-20

Description

Benzalkonium Chloride, 0.5%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium Chloride, 0.5%

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 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

Warnings

For external use only

Directions
  • wet hands and apply product
  • scrub hands and forearms
  • rinse thoroughly and dry
Do Not Use
  • in eyes
Active Ingredient

Benzalkonium Chloride, 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1 800 328 0026
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

NDC 47593-585-59 ECOLAB

EQUI-STAT ™

Antimicrobial Hand Soap

Active Ingredient: 0.5% Benzalkonium Chloride

Antimicrobial Handwash for Healthcare

CHG Compatible

Net Contents

1250 mL (42.3 US fl oz) 6000235

This product may be patented | Este producto puede ser patentado: www.ecolab.com/patents

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

© 2022 Ecolab USA Inc. · All rights reserved | Todos los derechos reservados

Made in U.S.A. | Hecho en EE.UU.

www.ecolab.com · 771528/8501/0322


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 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

Purpose

Antiseptic handwash

Warnings

For external use only

Directions
  • wet hands and apply product
  • scrub hands and forearms
  • rinse thoroughly and dry
Do Not Use (Do not use)
  • in eyes
Active Ingredient (Active ingredient)

Benzalkonium Chloride, 0.5%

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
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)

NDC 47593-585-59 ECOLAB

EQUI-STAT ™

Antimicrobial Hand Soap

Active Ingredient: 0.5% Benzalkonium Chloride

Antimicrobial Handwash for Healthcare

CHG Compatible

Net Contents

1250 mL (42.3 US fl oz) 6000235

This product may be patented | Este producto puede ser patentado: www.ecolab.com/patents

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

© 2022 Ecolab USA Inc. · All rights reserved | Todos los derechos reservados

Made in U.S.A. | Hecho en EE.UU.

www.ecolab.com · 771528/8501/0322


Advanced Ingredient Data


Raw Label Data

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