Drug Facts 

Drug Facts 
SPL v1
SPL
SPL Set ID 2bf01fcc-04ba-4e20-b70a-bc3906d5d781
Route
TOPICAL
Published
Effective Date 2019-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Glycerin Hydroxyethyl Cellulose (5000 Cps At 1%) Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Sulisobenzone Edetate Sodium Citric Acid Monohydrate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-08-20
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

for washing to decrease bacteria on the skin.

Warnings

For external use only.

Directions
  • apply onto dry hands
  • lather and rinse thoroughly
Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

store at room temperature

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Glycerin, Hydroxyethylcellulose, Polyquaternium-7, Benzophenone-4, Tetrasodium EDTA, Fragrance (Parfum), Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Red 40 (CI 16035).

Questions Or Comments?

1-866-695-3030

When Using This Product

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor If

irritation ad redness develops and lasts.

Keep Out of Reach of Children.

In case of accidental ingestiong, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

for washing to decrease bacteria on the skin.

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • apply onto dry hands
  • lather and rinse thoroughly
Label Copy (Label copy)

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Glycerin, Hydroxyethylcellulose, Polyquaternium-7, Benzophenone-4, Tetrasodium EDTA, Fragrance (Parfum), Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Red 40 (CI 16035).

Questions Or Comments? (Questions or comments?)

1-866-695-3030

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 ad redness develops and lasts.

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

In case of accidental ingestiong, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:51.030488 · Updated: 2026-03-14T22:55:36.629297