drug facts

drug facts
SPL v4
SPL
SPL Set ID 70516b96-5394-4f67-92c4-c50601c25946
Route
topical
Published
Effective Date 2024-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (5.5 mg)
Inactive Ingredients
water hexylene glycol cocamine oxide polyethylene glycol 8000 glycerin cocamidopropyl pg-dimonium chloride phosphate methyl gluceth-20 phenoxyethanol myristic diisopropanolamide glyceryl mono- and dicaprylocaprate anhydrous citric acid guar gum peg-12 dimethicone (300 cst) alcohol .alpha.-tocopherol acetate potassium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-04-28

Purpose

Antiseptic handwash

Description

Benzalkonium Chloride 0.55%


Medication Information

Warnings
For external use only
Uses
  • for handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Directions
  • wet skin and spread a small amount on hands and forearms
  • scrub well, rinse thoroughly and dry
Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
Description

Benzalkonium Chloride 0.55%

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), hexylene glycol, cocamine oxide, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, phenoxyethanol, myristamide DIPA, caprylic/capric glycerides, citric acid, hydroxypropyl guar hydroxypypropyltrimonium chloride, PEG-12 dimethicone, ethanol, tocopheryl acetate, fragrance, potassium hydroxide

Section 53413-1

Questions? call 1-800-35-CLEAN (352-5326)

Do Not Use
  • In eyes
Active Ingredient

Benzalkonium Chloride 0.55%

When Using This Product 
  • if in eyes, rinse promptly and thoroughly with water.
  • discontinue use if irritation and redness develop.
Principal Display Panel and Representative Label

6100958

Premium Antibacterial Foam Hand Soap

Active ingredient: Benzalkonium Chloride, 0.55%

761095/5401/0321

1250 mL (42 US FL OZ)

Ecolab · 1 Ecolab Place · St. Paul MN 55102

USA ·tel: 1 800 35 CLEAN (352 5326)

© 2021 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.ecolab.com


Structured Label Content

Warnings
For external use only
Uses
  • for handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Directions
  • wet skin and spread a small amount on hands and forearms
  • scrub well, rinse thoroughly and dry
Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
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), hexylene glycol, cocamine oxide, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, phenoxyethanol, myristamide DIPA, caprylic/capric glycerides, citric acid, hydroxypropyl guar hydroxypypropyltrimonium chloride, PEG-12 dimethicone, ethanol, tocopheryl acetate, fragrance, potassium hydroxide

Section 53413-1 (53413-1)

Questions? call 1-800-35-CLEAN (352-5326)

Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.55%

When Using This Product  (When using this 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)

6100958

Premium Antibacterial Foam Hand Soap

Active ingredient: Benzalkonium Chloride, 0.55%

761095/5401/0321

1250 mL (42 US FL OZ)

Ecolab · 1 Ecolab Place · St. Paul MN 55102

USA ·tel: 1 800 35 CLEAN (352 5326)

© 2021 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

www.ecolab.com


Advanced Ingredient Data


Raw Label Data

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