drug facts

drug facts
SPL v1
SPL
SPL Set ID c3cd4b9f-e5b1-4319-801c-a5e01daa6da0
Route
topical
Published
Effective Date 2017-06-01
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 polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) edetate sodium sodium citrate citric acid monohydrate sulisobenzone methylchloroisothiazolinone methylisothiazolinone ext. d&c violet no. 2

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-05-31
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings
  • For external use only.
Uses
  • helps eliminate bacteria on hands.
Purpose

Antibacterial

Directions
  • Pump onto dry hands.
  • Work into a rich foamy lather, rinse thoroughly and dry.
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, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ext. Violet 2 (CI 60730).

Description

Benzalkonium Chloride 0.13%

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, 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
  • Pump onto dry hands.
  • Work into a rich foamy lather, rinse thoroughly and dry.
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, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ext. Violet 2 (CI 60730).

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, 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: 2026-02-15T11:56:21.760003 · Updated: 2026-03-14T22:54:46.340416