Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ee12ea49-db63-4fbf-84f8-d49ecc274b31
Route
TOPICAL
Published
Effective Date 2016-10-31
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 Green Tea Leaf Aloe Vera Leaf Sodium Citrate Xanthan Gum Edetate Sodium Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Decyl Glucoside Citric Acid Monohydrate Methylchloroisothiazolinone Methylisothiazolinone Ext. D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-10-27
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
  • Use to refill a foaming pump bottle.
  • From the pump bottle, pum onto dry hands.
  • Work into a rich foamy lather, rinse thoroughly and dry.
Label Copy

Active Ingredient

Benzalkonium chloride 0.13%

Other Information

Store at room temperature.

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Glycerin, Fragrance (Parfum), Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Sodium Citrate, Xanthan Gum, Tetrasodium EDTA, Polyquaternium-7, Decyl Glucoside, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Ext. Violet 2 (CI 60730).

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
  • Use to refill a foaming pump bottle.
  • From the pump bottle, pum onto dry hands.
  • Work into a rich foamy lather, rinse thoroughly and dry.
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, Glycerin, Fragrance (Parfum), Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Sodium Citrate, Xanthan Gum, Tetrasodium EDTA, Polyquaternium-7, Decyl Glucoside, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Ext. Violet 2 (CI 60730).

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: 2026-02-15T11:56:12.204017 · Updated: 2026-03-14T22:54:30.332332