2c5ad7aa-0b16-4535-a45e-cc1cdd7d6ff7

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
Purpose

Antiseptic handwash

Description

Benzalkonium Chloride 0.1%

Medication Information

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

Uses

■ For hand washing to decrease bacteria on the skin

Purpose

Antiseptic

handwash

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

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

Description

Benzalkonium Chloride 0.1%

Active Ingredient

Benzalkonium Chloride 0.1%

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

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

Uses

■ For hand washing to decrease bacteria on the skin

Purpose (PURPOSE)

Antiseptic

handwash

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

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

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.1%

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

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