SPL v1
SPL
SPL Set ID 484c8ff5-cc11-b646-e063-6394a90a5f50
Route
TOPICAL
Published
Effective Date 2026-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Polyaminopropyl Biguanide Aloe Vera Leaf Glycerin Edetic Acid Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-13

Description

Benzalkonium Chloride 0.1%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%

Use

For hand washing to decrease bacteria on the skin

Section 51945-4

Warning

For external use only.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Do Not Use

in the eyes.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Polyaminopropyl Biguanide, Aloe Barbadensis Extract, Glycerin, Citric acid, EDTA 2Na, Water

Stop Use and Ask A Doctor If:

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep Out of Reach of Children.

If swallowed, get medical help or contact poison Control Centre right away.


Structured Label Content

Use

For hand washing to decrease bacteria on the skin

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warning

For external use only.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Do Not Use (Do not use)

in the eyes.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.1%

Inactive Ingredients (Inactive ingredients)

Polyaminopropyl Biguanide, Aloe Barbadensis Extract, Glycerin, Citric acid, EDTA 2Na, Water

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact poison Control Centre right away.


Advanced Ingredient Data


Raw Label Data

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