SPL v1
SPL
SPL Set ID 42b0b139-ef5c-4192-b0e4-2502295934e7
Route
TOPICAL
Published
Effective Date 2021-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Sodium Chloride Glycerin Sodium Laureth Sulfate Cocamidopropyl Betaine Coco Monoethanolamide Peg-150 Distearate Bronopol Edetate Disodium Anhydrous Phenoxyethanol Benzophenone Citric Acid Monohydrate Water Glycol Distearate Laureth-10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-02
Description

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride (0.13%)

Uses

For hand washing to decrease bacteria on the skin.

Label

Section 50565-1

Warnings

For external use only.

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

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

Keep out of reach of children if swallowed, get medical help or contact a Poison control center right away.

Directions

• Pump into hands.

• Lather vigorously for at least 15 seconds.

• Rinse and dry thoroughly.

Active Ingredient

Benzalkonium Chloride (0.13%)

Inactive Ingredient

Water, Sodium Laureth Sulphate,Sodium Laureth sulfate & Glycol Distearate & Cocamide MEA & Laureth - 10, Cocamido Propyl Betaine,

Cocomonoethanolamide, Sodium Chloride, Glycerine,Perfume, PEG 150 Distearate, Bronopol, Disodium EDTA,Phenoxyethanol, Benzophenone 3, Citric Acid.

Structured Label Content

Uses

For hand washing to decrease bacteria on the skin.

Label

Section 50565-1 (50565-1)

Purpose

Antibacterial

Warnings

For external use only.

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

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

Keep out of reach of children if swallowed, get medical help or contact a Poison control center right away.

Directions

• Pump into hands.

• Lather vigorously for at least 15 seconds.

• Rinse and dry thoroughly.

Active Ingredient (Active ingredient)

Benzalkonium Chloride (0.13%)

Inactive Ingredient (Inactive ingredient)

Water, Sodium Laureth Sulphate,Sodium Laureth sulfate & Glycol Distearate & Cocamide MEA & Laureth - 10, Cocamido Propyl Betaine,

Cocomonoethanolamide, Sodium Chloride, Glycerine,Perfume, PEG 150 Distearate, Bronopol, Disodium EDTA,Phenoxyethanol, Benzophenone 3, Citric Acid.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:22.383642 · Updated: 2026-03-14T22:59:19.689823