drug facts

drug facts
SPL v1
SPL
SPL Set ID 64a13de7-25ac-40b8-9c89-0c51668db76d
Route
topical
Published
Effective Date 2016-08-22
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 sodium citrate xanthan gum polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) decyl glucoside edetate sodium citric acid monohydrate green tea leaf aloe vera leaf methylchloroisothiazolinone methylisothiazolinone fd&c red no. 4 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-08-18
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Uses

for hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • apply onto dry hands.
  • lather and rinse thoroughly.
Other Information

store at room temperature.

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Glycerin, Fragrance (Parfum), Sodium Citrate, Xanthan Gum, Polyquaternium-7, Decyl Glucoside, Tetrasodium EDTA, Citric Acid, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 5 (CI 19140).

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 and redness develop and last.

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

for hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • apply onto dry hands.
  • lather and rinse thoroughly.
Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Glycerin, Fragrance (Parfum), Sodium Citrate, Xanthan Gum, Polyquaternium-7, Decyl Glucoside, Tetrasodium EDTA, Citric Acid, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 5 (CI 19140).

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 and redness develop and last.

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: 2026-02-15T11:56:09.260615 · Updated: 2026-03-14T22:54:24.786834