SPL v1
SPL
SPL Set ID 07d48c66-4f1e-40c5-9cc8-bbb37de05537
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 Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40

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, fragrance, benzoic acid, sorbic acid, citric acid, blue 1 (CI 42090), red 40 (CI 16035)

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, fragrance, benzoic acid, sorbic acid, citric acid, blue 1 (CI 42090), red 40 (CI 16035)

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: 2026-02-15T11:58:52.613871 · Updated: 2026-03-14T22:58:41.209834