Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b1c677b8-4ab0-470a-b83b-be85490ebdbf
Route
TOPICAL
Published
Effective Date 2020-03-18
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 Hypromelloses Aloe Vera Leaf Green Tea Leaf Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Sodium Sodium Citrate Citric Acid Monohydrate Sulisobenzone Methylchloroisothiazolinone Methylisothiazolinone D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-20
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use
  • Helps eliminate bacteria on the skin.
Warnings

For external use only.

Directions
  • Apply onto dry hands. Work into a lather, rinse and dry 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, Camellia Sinensis Leaf Extract, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 10 (CI 47005), Green 3 (CI 42053).

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Keep Out of Reach of Children.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask Doctor If
  • irritation or redness develops and lasts.

Structured Label Content

Use
  • Helps eliminate bacteria on the skin.
Purpose

Antibacterial

Warnings

For external use only.

Directions
  • Apply onto dry hands. Work into a lather, rinse and dry 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, Camellia Sinensis Leaf Extract, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 10 (CI 47005), Green 3 (CI 42053).

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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.
Stop Using This Product and Ask Doctor If (Stop using this product and ask doctor if)
  • irritation or redness develops and lasts.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:04.311109 · Updated: 2026-03-14T22:55:59.360416