35025154-cf81-407c-ae15-870298db2841

SPL v1
SPL
SPL Set ID 35025154-cf81-407c-ae15-870298db2841
Route
topical
Published
Effective Date 2020-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cetrimonium chloride glycerin lauramidopropylamine oxide cocamidopropyl betaine sodium chloride peg-120 methyl glucose dioleate citric acid monohydrate edetate sodium tetrahydrate methylchloroisothiazolinone methylisothiazolinone

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-04
Purpose

Antibacterial   

Description

Benzalkonium chloride 0.13% w/v

Medication Information

Warnings

For external use only

When using this product, avoid contact with eyes. In case of contact with eyes, flush with water.

Stop use and ask a doctor if irritation or redness develops.

Purpose

Antibacterial   

Directions

Pump into hands & wet as needed. Lather vigorously for at least 20 seconds. Wash skin, rinse thoroughly and dry

Inactive Ingredients

Water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

Description

Benzalkonium chloride 0.13% w/v

Use

For handwashing to decrease bacteria on the skin

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Benzalkonium chloride 0.13% w/v

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only

When using this product, avoid contact with eyes. In case of contact with eyes, flush with water.

Stop use and ask a doctor if irritation or redness develops.

Purpose

Antibacterial   

Directions

Pump into hands & wet as needed. Lather vigorously for at least 20 seconds. Wash skin, rinse thoroughly and dry

Inactive Ingredients (Inactive ingredients)

Water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

Use

For handwashing to decrease bacteria on the skin

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Benzalkonium chloride 0.13% w/v

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: 2026-02-15T11:58:24.918323 · Updated: 2026-03-14T22:57:57.287270