SPL v1
SPL
SPL Set ID 9a6f9047-aa6f-408d-abea-d367273ec154
Route
TOPICAL
Published
Effective Date 2017-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Glycerin Decyl Glucoside Hydroxyethyl Cellulose (5000 Cps At 1%) Aloe Vera Leaf Polyoxyl 40 Hydrogenated Castor Oil Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Sodium Citric Acid Monohydrate Sodium Citrate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-11
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 wet 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, Glyceirn, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

When Using This Product

avoid contact with eyes. If contact occurs, rinse eyes 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 wet 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, Glyceirn, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse eyes 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: 2026-02-15T11:56:18.253397 · Updated: 2026-03-14T22:54:41.714370