SPL v1
SPL
SPL Set ID 608b568c-5441-405a-b218-51333fe9fd9b
Route
TOPICAL
Published
Effective Date 2016-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.003 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Cocamidopropyl Pg-dimonium Chloride Phosphate Peg-6 Cocamide Laurtrimonium Chloride Methylisothiazolinone Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-10-01
Description

Active Ingredient Benzalkonium Chloride 0.13% w/w

Medication Information

Warnings and Precautions

Warnings

For external use only. Do not use in the eyes. If eye contact occurs, flush eyes with water.

Stop use and ask a doctor if redness and irritation occur and last for more than 72 hours.

Indications and Usage

Uses  For handwashing to decrease bacteria on skin

Dosage and Administration

Directions  Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Description

Active Ingredient Benzalkonium Chloride 0.13% w/w

Section 50565-1

Keep out of reach of children. If swallowed, contact a physician or poison control center. 

Section 51727-6

Inactive Ingredients

water, cocamidopropyl PG-dimonium chloride phosphate, cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride,  iodopropynyl butylcarbamate, methylisothiazolinone .

Section 51945-4

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Structured Label Content

Indications and Usage (34067-9)

Uses  For handwashing to decrease bacteria on skin

Dosage and Administration (34068-7)

Directions  Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Warnings and Precautions (34071-1)

Warnings

For external use only. Do not use in the eyes. If eye contact occurs, flush eyes with water.

Stop use and ask a doctor if redness and irritation occur and last for more than 72 hours.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, contact a physician or poison control center. 

Section 51727-6 (51727-6)

Inactive Ingredients

water, cocamidopropyl PG-dimonium chloride phosphate, cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride,  iodopropynyl butylcarbamate, methylisothiazolinone .

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:03.046012 · Updated: 2026-03-14T22:54:14.381059