drug facts

drug facts
SPL v1
SPL
SPL Set ID b26e4644-e6b3-476e-bdcc-a06634a57485
Route
topical
Published
Effective Date 2017-03-30
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 sodium chloride coco monoethanolamide peg-120 methyl glucose dioleate citric acid monohydrate edetate sodium sodium sulfate methylchloroisothiazolinone methylisothiazolinone fd&c red no. 40 fd&c yellow no. 5 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-03-29
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Uses

For hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • Apply onto dry hands.
  • Lather and rinse thoroughly with water.
Other Information

Store at room temperature.

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredients

Benzalkonium Chloride 0.13%

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor

if irritation or redness develops and lasts for more than 72 hours.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only.

Uses

For hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • Apply onto dry hands.
  • Lather and rinse thoroughly with water.
Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Label Copy

Active Ingredients (Active ingredients)

Benzalkonium Chloride 0.13%

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or redness develops and lasts for more than 72 hours.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:18.161506 · Updated: 2026-03-14T22:54:40.661795