Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d04bfa46-79d9-440a-8785-dcfab2a0909a
Route
TOPICAL
Published
Effective Date 2016-10-21
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 2016-10-20
Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Directions
  • use only to refill a foaming hand soap pump bottle.
  • from pump bottle, 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, 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).

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

For hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • use only to refill a foaming hand soap pump bottle.
  • from pump bottle, 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, 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).

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: 2026-02-15T11:56:12.128023 · Updated: 2026-03-14T22:54:30.332332