SPL v1
SPL
SPL Set ID 2c5ad7aa-0b16-4535-a45e-cc1cdd7d6ff7
Route
TOPICAL
Published
Effective Date 2022-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 1)
Inactive Ingredients
Water Phenoxyethanol Glycerin Sodium Benzoate Polysorbate 20 Edetate Disodium Anhydrous Citric Acid Monohydrate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-30
Description

Benzalkonium Chloride 0.1%

Purpose

Antiseptic handwash

Medication Information

Purpose

Antiseptic

handwash

Description

Benzalkonium Chloride 0.1%

Uses

■ For hand washing to decrease bacteria on the skin

Warnings

For external use only



Do not use

■ If you are allergic to any of the ingredients



When using this product

■ Do not get into eyes. If contact occurs, rinse thoroughly with water



Stop use and ask a doctor if

■ Irritation or rash develops and continues for more than 72 hours



Keep out of reach of children

■ Unless under adult supervision

■ If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ Use entire wipe to thoroughly wipe hands, fingers, and wrists

■ To sanitize, use multiple wipes

■ Discard after single use

■ Keep label closed to prevent moisture loss

Active Ingredient

Benzalkonium Chloride 0.1%

Other Information

■ Read the directions and warnings before use

■ Avoid freezing and excessive heat

Inactive Ingredients

Water (Aqua), Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Citric Acid, Tocopheryl Acetate

Questions Or Comments?

■ E-mail: [email protected]

■ Call 1-212-484-2621

Keep Out of Reach of Children

■ Unless under adult supervision

■ If swallowed, get medical help or contact a Poison Control Center right away

Package Label.principal Display Panel

Structured Label Content

Uses

■ For hand washing to decrease bacteria on the skin

Purpose (PURPOSE)

Antiseptic

handwash

Warnings (WARNINGS)

For external use only



Do not use

■ If you are allergic to any of the ingredients



When using this product

■ Do not get into eyes. If contact occurs, rinse thoroughly with water



Stop use and ask a doctor if

■ Irritation or rash develops and continues for more than 72 hours



Keep out of reach of children

■ Unless under adult supervision

■ If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ Use entire wipe to thoroughly wipe hands, fingers, and wrists

■ To sanitize, use multiple wipes

■ Discard after single use

■ Keep label closed to prevent moisture loss

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.1%

Other Information (Other information)

■ Read the directions and warnings before use

■ Avoid freezing and excessive heat

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Citric Acid, Tocopheryl Acetate

Questions Or Comments? (Questions or Comments?)

■ E-mail: [email protected]

■ Call 1-212-484-2621

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

■ Unless under adult supervision

■ If swallowed, get medical help or contact a Poison Control Center right away

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:57.408634 · Updated: 2026-03-14T23:00:12.227844