4639cf1b-198b-400d-81bb-8640a593cff7

SPL v4

SPL

SPL Set ID 4639cf1b-198b-400d-81bb-8640a593cff7

Route

topical

Published

Effective Date 2020-10-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (1 mg)

Inactive Ingredients

water cocamidopropyl betaine glycerin cetrimonium chloride benzyl alcohol edetate disodium anhydrous benzoic acid sorbic acid

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-10-08

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%

Medication Information

Warnings

For external use only.

Purpose

Antiseptic

Directions

Pump onto dry skin. Lather vigorously for 20 seconds.
Rinse hands and dry thoroughly.

Inactive Ingredients

Water, cocamidopropyl betaine, glycerin, cetrimonium chloride, benzyl alcohol, disodium EDTA, benzoic acid, sorbic acid

Description

Benzalkonium Chloride 0.1%

Use

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 50567-7

When using this product keep out of eyes. In case of contact eyes with water.

Stop use and consult a doctor if irritation or redness develops.

Active Ingredient

Benzalkonium Chloride 0.1%

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only.

Purpose

Antiseptic

Directions

Pump onto dry skin. Lather vigorously for 20 seconds.
Rinse hands and dry thoroughly.

Inactive Ingredients (Inactive ingredients)

Water, cocamidopropyl betaine, glycerin, cetrimonium chloride, benzyl alcohol, disodium EDTA, benzoic acid, sorbic acid

Use

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 50567-7 (50567-7)

When using this product keep out of eyes. In case of contact eyes with water.

Stop use and consult a doctor if irritation or redness develops.

Active Ingredient

Benzalkonium Chloride 0.1%

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETRIMONIUM CHLORIDE", "unii": "UC9PE95IBP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBIC ACID", "unii": "X045WJ989B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "To decrease bacteria on the skin.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product keep out of eyes. In case of contact eyes with water. Stop use and consult a doctor if irritation or redness develops.", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Pump onto dry skin. Lather vigorously for 20 seconds. Rinse hands and dry thoroughly.", "Active Ingredient": "Benzalkonium Chloride 0.1%", "Inactive ingredients": "Water, cocamidopropyl betaine, glycerin, cetrimonium chloride, benzyl alcohol, disodium EDTA, benzoic acid, sorbic acid"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:06.168805 · Updated: 2026-03-14T22:58:56.195499