SPL v1
SPL
SPL Set ID 621b2e99-9363-42b7-8487-fabf2449ac54
Route
TOPICAL
Published
Effective Date 2021-02-01
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 Fd&c Red No. 40 Water Glycol Distearate Laureth-10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-01-29
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, FD & C Red 40, CI. No 16035.

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, FD & C Red 40, CI. No 16035.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:23.070596 · Updated: 2026-03-14T22:59:19.689823