Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4cba6960-9208-411e-ad58-f602f3461106
Route
TOPICAL
Published
Effective Date 2017-05-24
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 Powdered Cellulose Aloe Vera Leaf Coconut Bambusa Vulgaris Top Propylene Glycol Edetate Sodium Sodium Citrate Citric Acid Monohydrate Sulisobenzone Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-23
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.

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, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

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

Uses
  • helps eliminate bacteria on hands.
Purpose

Antibacterial

Warnings

For external use only.

Directions
  • apply onto dry hands
  • 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, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

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

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Source: dailymed · Ingested: 2026-02-15T11:56:19.412425 · Updated: 2026-03-14T22:54:44.018094