drug facts

drug facts
SPL v1
SPL
SPL Set ID 96afe99e-7446-4ddf-9022-eb82bbd0a1e6
Route
topical
Published
Effective Date 2017-05-10
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 fd&c yellow no. 5 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-05-09
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only

Uses

helps eliminate bacteria on hands

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, 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 5 (CI 19140), Red 33 (CI 17200).

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 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

Warnings

For external use only

Uses

helps eliminate bacteria on hands

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, 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 5 (CI 19140), Red 33 (CI 17200).

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 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: 2026-02-15T11:56:19.063410 · Updated: 2026-03-14T22:54:43.254033