drug facts

drug facts
SPL v2
SPL
SPL Set ID 25c11411-d30c-450a-ab78-b5a8624d7c7a
Route
topical
Published
Effective Date 2018-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cetrimonium chloride lauramidopropylamine oxide glycerin lauramine oxide sodium chloride coco monoethanolamide peg-120 methyl glucose dioleate citric acid monohydrate edetate sodium sodium benzoate 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 2018-04-11
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Purpose

Antibacterial

Directions
  • apply onto dry hands.
  • lather and rinse thoroughly.
Other Information
  • store at room temperature.
Inactive Ingredients

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

Description

Benzalkonium Chloride 0.13%

Use

for handwashing to decrease bacteria on the skin.

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

When Using This Product
  • avoid contact with eyes. In case of contact, rinse thoroughly with water.
Stop Use and Ask A Doctor If
  • irritation or redness develops and lasts.
Keep Out of Reach of Children.

In case of accidental ingestion, gem medical help or contact a Poison Control Center immediately.

Structured Label Content

Warnings

For external use only.

Purpose

Antibacterial

Directions
  • apply onto dry hands.
  • lather and rinse thoroughly.
Other Information (Other information)
  • store at room temperature.
Inactive Ingredients (Inactive ingredients)

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

Use

for handwashing to decrease bacteria on the skin.

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

When Using This Product (When using this product)
  • avoid contact with eyes. In case of contact, rinse thoroughly with water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation or redness develops and lasts.
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, gem medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.860508 · Updated: 2026-03-14T22:55:08.159087