5d46f12d-d095-44ac-e053-2a91aa0a0386

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

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Medication Information

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.

Uses

For Hand washing to decrease bacteria on the skin

Recommended for repeated use

Purpose

Antimicrobial

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.

Inactive Ingredients

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

Description

Benzalkonium Chloride 0.13%

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

Active Ingredient

Benzalkonium Chloride 0.13%

Questions Or Comments?

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

Structured Label Content

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.

Uses

For Hand washing to decrease bacteria on the skin

Recommended for repeated use

Purpose

Antimicrobial

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.

Inactive Ingredients (Inactive ingredients)

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

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)

Active Ingredient

Benzalkonium Chloride 0.13%

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