Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0435dd4e-fd9c-4f21-8db3-a10d38882c67
Route
TOPICAL
Published
Effective Date 2017-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Polysorbate 20 Glycerin Decyl Glucoside Hydroxyethyl Cellulose (5000 Cps At 1%) Aloe Vera Leaf Green Tea Leaf Propylene Glycol Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Sodium Sodium Citrate Citric Acid Monohydrate Sulisobenzone Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Ext. D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-13
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses
  • helps eliminate bacteria on the skin.
Warnings

For external use only.

Directions
  • Apply onto dry hands, work into a lather and rinse thoroughly.
Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • store at room temperature.
Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinione, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Keep Out of Reach of Children.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask Doctor
  • if irritation and redness develops and lasts.

Structured Label Content

Uses
  • helps eliminate bacteria on the skin.
Purpose

Antibacterial

Warnings

For external use only.

Directions
  • Apply onto dry hands, work into a lather and rinse thoroughly.
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, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinione, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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.
Stop Using This Product and Ask Doctor (Stop using this product and ask doctor)
  • if irritation and redness develops and lasts.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:18.263430 · Updated: 2026-03-14T22:54:41.714370