Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 465a4564-0af2-4fbb-8c4c-61e05ddf7bbc
Route
TOPICAL
Published
Effective Date 2025-07-18
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 Myristamide Dipa Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Myristamine Oxide Methyl Gluceth-20 Glyceryl Caprylate/caprate Anhydrous Citric Acid Peg-12 Dimethicone Potassium Citrate Blue 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-22

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, cocamidopropyl pg-dimoniumchloride phosphate, phenoxyethanol, Myristamide dipa, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate,citric acid, PEG-12 dimethicone, potassium citrate, polyquaternium-7, fragrance, blue 1

Section 53413-1

Questions? call 1 866 781 8787

Warning
For external use only
Directions
  • wet hands and apply foam
  • 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)
  • EMERGENCY HELATH INFORMATION: 1 800 328 0026, If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
When Using the Product
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Representative Label and Principal Display Panel

NDC 47593-582-70

ECOLAB

EQUI-MILD™

Foam Antimicrobial

Hand Soap

Active Ingredient: 0.5% Benzalkonium chloride

Net Contents

40.6 US FL OZ (1200 mL) 6000375

Ecolab Inc 1 Ecolab Place St. Paul MN 55102 USA

© 2024 Ecolab USA Inc. · All rights reserved

Made in United States

784134/8500/1124


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, cocamidopropyl pg-dimoniumchloride phosphate, phenoxyethanol, Myristamide dipa, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate,citric acid, PEG-12 dimethicone, potassium citrate, polyquaternium-7, fragrance, blue 1

Section 53413-1 (53413-1)

Questions? call 1 866 781 8787

Purpose

Antiseptic handwash

Warning
For external use only
Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinse thoroughly and dry
Do Not Use (Do not use)
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HELATH INFORMATION: 1 800 328 0026, If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
When Using the Product (When using the product)
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Representative Label and Principal Display Panel

NDC 47593-582-70

ECOLAB

EQUI-MILD™

Foam Antimicrobial

Hand Soap

Active Ingredient: 0.5% Benzalkonium chloride

Net Contents

40.6 US FL OZ (1200 mL) 6000375

Ecolab Inc 1 Ecolab Place St. Paul MN 55102 USA

© 2024 Ecolab USA Inc. · All rights reserved

Made in United States

784134/8500/1124


Advanced Ingredient Data


Raw Label Data

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