SPL v1
SPL
SPL Set ID f57c1496-a11f-4ea4-925d-90c7faa3a153
Route
TOPICAL
Published
Effective Date 2021-02-04
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 Fd&c Red No. 40 D&c Red No. 33 Laureth-10 Glycol Distearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-03
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, CI. No. 17200, FD & C Red 40,CI. No. 16035 , D and C Red 33.

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, CI. No. 17200, FD & C Red 40,CI. No. 16035 , D and C Red 33.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:23.122813 · Updated: 2026-03-14T22:59:19.689823