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SPL v3

SPL

SPL Set ID 5d46f12d-d095-44ac-e053-2a91aa0a0386

Route

TOPICAL

Published

Effective Date 2017-11-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.1 g)

Inactive Ingredients

Water Glycerin Lauramine Oxide Peg-120 Methyl Glucose Dioleate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-11-06

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Uses

For Hand washing to decrease bacteria on the skin

Recommended for repeated use

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Section 51945-4

Warnings

For External use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Rinse with potable water.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid

Questions Or Comments?

1-813-815-0530 or www.protectuguard.com

Structured Label Content

Uses

For Hand washing to decrease bacteria on the skin

Recommended for repeated use

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For External use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Rinse with potable water.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid

Questions Or Comments? (Questions or comments?)

1-813-815-0530 or www.protectuguard.com

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURAMINE OXIDE", "unii": "4F6FC4MI8W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-120 METHYL GLUCOSE DIOLEATE", "unii": "YM0K64F20V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For Hand washing to decrease bacteria on the skin Recommended for repeated use", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.", "50567-7": "When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.", "Purpose": "Antimicrobial", "Warnings": "For External use only. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Directions": "Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands for 15 seconds. Rinse with potable water.", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid", "Questions or comments?": "1-813-815-0530 or www.protectuguard.com"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:05.069266 · Updated: 2026-03-14T22:55:59.360416