Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f79f0b4f-8267-4bee-aa4b-46f88ca3c6c1
Route
TOPICAL
Published
Effective Date 2020-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 1)
Inactive Ingredients
Water Polysorbate 20 Ascorbic Acid Edetate Disodium Anhydrous Phenoxyethanol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-26
Description

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%

Use

Antiseptic Cleanser, helps decrease bacteria on skin.

Warnings

For external use only.

Directions
  • Lift tab and poull out towel to wipe hands thoroughly for 30 seconds. Allow to air dry.
  • Reseal after use to prevent moisture from evaporating.
  • Children under 6 years of age should be supervised when using this product.
Label Copy

Active Ingredient

Benzalkonium Chloride 0.1%

Other Information
  • store at room temperature.
Inactive Ingredients

Water (Aqua), Polysorbate 20, Ascorbic Acid (Vitamin C), Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

When Using This Product

Avoid contact with the eyes; in case of contact, flush eyes with water

Stop Use and Ask A Doctor If

irritation or redness develops and persists.

Keep Out of Reach of Children.

If ingested get medical help or contact a Poison Control Center right away.

Structured Label Content

Use

Antiseptic Cleanser, helps decrease bacteria on skin.

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • Lift tab and poull out towel to wipe hands thoroughly for 30 seconds. Allow to air dry.
  • Reseal after use to prevent moisture from evaporating.
  • Children under 6 years of age should be supervised when using this product.
Label Copy (Label copy)

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.1%

Other Information (Other information)
  • store at room temperature.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Polysorbate 20, Ascorbic Acid (Vitamin C), Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

When Using This Product (When using this product)

Avoid contact with the eyes; in case of contact, flush eyes with water

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

irritation or redness develops and persists.

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

If ingested get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:57.656826 · Updated: 2026-03-14T22:58:46.689678