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SPL v1
SPL
SPL Set ID 00dc873f-7995-476f-ad0f-6f4b336affcb
Route
topical
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
cocamidopropyl betaine dmdm hydantoin disodium hedta citric acid monohydrate verbena officinalis water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-29
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only

Purpose

Antibacterial

Directions

Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly

Inactive Ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Verbena Officinalis Extract

Description

Benzalkonium Chloride 0.13%

Use

■ To decrease bacteria on hands

Section 50566-9

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

Section 51945-4

Active Ingredient

Benzalkonium Chloride 0.13%

Keep Out of Reach of Children

Keep out of reach of children

Structured Label Content

Warnings (WARNINGS)

For external use only

Purpose

Antibacterial

Directions

Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly

Inactive Ingredients (Inactive ingredients)

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Verbena Officinalis Extract

Use

■ To decrease bacteria on hands

Section 50566-9 (50566-9)

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

Section 51945-4 (51945-4)

Active Ingredient

Benzalkonium Chloride 0.13%

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

Keep out of reach of children

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:04.509708 · Updated: 2026-03-14T22:57:27.471846