Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 15e60c2d-c956-4043-9708-f741156876d3
Route
TOPICAL
Published
Effective Date 2020-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 1)
Inactive Ingredients
Water Polysorbate 20 Edetate Disodium Anhydrous Phenoxyethanol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-06
Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Use

Antiseptic cleanser, helps decrease bacteria on skin.

Warnings

For external use only

Directions
  • Lift tab and pull out twoel 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

Questions?

1-800-548-4097

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Store below 110°F (43°C). May discolor certain fabrics or surfaces.

Inactive Ingredients

Water (Aqua), Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

When Using This Product

Avoid contact with the eyes; in case of contact, flus eyes with water.

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 pull out twoel 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)

Questions?

1-800-548-4097

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)

Store below 110°F (43°C). May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

When Using This Product (When using this product)

Avoid contact with the eyes; in case of contact, flus eyes with water.

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: 2026-02-15T11:58:51.534841 · Updated: 2026-03-14T22:58:38.353182