drug facts

drug facts
SPL v3
SPL
SPL Set ID 8f28a012-a594-4f7b-af41-75dd7ccda080
Route
topical
Published
Effective Date 2016-02-05
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 coco monoethanolamide sodium chloride 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 2016-02-04
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only

Uses
  • helps eliminate bacteria on hands.
Purpose

Antibacterial

Directions
  • apply onto wet hands.
  • lather and rinse thoroughly.
Other Information

store at room temperature.

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, 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 Ingredient

Benzalkonium Chloride 0.13%

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse eyes 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, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Warnings

For external use only

Uses
  • helps eliminate bacteria on hands.
Purpose

Antibacterial

Directions
  • apply onto wet hands.
  • lather and rinse thoroughly.
Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, 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 Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse eyes 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, get 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: 2026-02-15T11:56:03.793734 · Updated: 2026-03-14T22:54:15.762833