Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 89bdf6e8-9d73-4f39-8a5d-4d6e8f4081c4
Route
TOPICAL
Published
Effective Date 2019-07-22
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 Sodium Chloride Coco Monoethanolamide Peg-120 Methyl Glucose Dioleate Tangerine Peel Green Tea Leaf Ginger Citric Acid Monohydrate Edetate Sodium Sodium Sulfate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Yellow No. 5 Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-07-18
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

helps eliminate bacteria on hands.

Warnings

For external use only.

Label Copy

Directions 
  • apply onto wet hands.
  • lather and rinse thoroughly.
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

store at room temperature. 

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

When Using This Product
  • avoid contact with eyes. In case of contact, rinse 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 Use and Ask A Doctor If 
  • irritation or redness develops and lasts.

Structured Label Content

Uses

helps eliminate bacteria on hands.

Purpose

Antibacterial

Warnings

For external use only.

Label Copy (Label copy)

Directions 
  • apply onto wet hands.
  • lather and rinse thoroughly.
Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)

store at room temperature. 

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:50.327133 · Updated: 2026-03-14T22:55:35.679907