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
Description

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

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.

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

Package Label Principal Display Panel

Structured Label Content

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.

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 (Inactive ingredients)

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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