Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 6f31933e-e88f-4353-aea9-fdcd89e26a26
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 Hydroxyethyl Cellulose (5000 Cps At 1%) Aloe Vera Leaf Coconut Bambusa Vulgaris Top Propylene Glycol Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Sodium Sodium Citrate Citric Acid Monohydrate Sulisobenzone Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-26
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, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

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 and redness develop and last.

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 (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, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

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 and redness develop and last.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:04.304554 · Updated: 2026-03-14T22:55:59.360416