drug facts

drug facts
SPL v2
SPL
SPL Set ID 60da90e4-3467-4aea-9c44-09a9ef718995
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 propylene glycol-dimonium chloride phosphate phenoxyethanol myristic diisopropanolamide myristamine oxide methyl gluceth-20 glyceryl mono- and dicaprylocaprate alcohol peg-12 dimethicone 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 2018-10-29

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 physician 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, polyquaternium-7, fragrance, potassium hydroxide, blue 1

Section 53413-1

Questions? call 1-866-781-8787

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
Representative Label and Principal Display Panel

PROCLEAN

ADVANCED

ANTIBACTERIAL

HAND SOAP

Antibacterial liquid hand soap

Active ingredient: Benzalkonim chloride 0.5%

6102017

3.78 L (1 US GAL)

For more ingredient information visit: www.shamrockfoodservice.com/proclean

This product may be patented

For questions or comments, call 1-866-444-7450.

Manufactured by

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

© 2018  Ecolab USA Inc. · All rights reserved

774470/5400/1018

Distributed by Shamrock Foods

Phoenix, AZ


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 physician 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, polyquaternium-7, fragrance, potassium hydroxide, blue 1

Section 53413-1 (53413-1)

Questions? call 1-866-781-8787

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
Representative Label and Principal Display Panel

PROCLEAN

ADVANCED

ANTIBACTERIAL

HAND SOAP

Antibacterial liquid hand soap

Active ingredient: Benzalkonim chloride 0.5%

6102017

3.78 L (1 US GAL)

For more ingredient information visit: www.shamrockfoodservice.com/proclean

This product may be patented

For questions or comments, call 1-866-444-7450.

Manufactured by

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

© 2018  Ecolab USA Inc. · All rights reserved

774470/5400/1018

Distributed by Shamrock Foods

Phoenix, AZ


Advanced Ingredient Data


Raw Label Data

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