drug facts

drug facts
SPL v1
SPL
SPL Set ID bcc35b0f-d108-42c8-976e-d6a8cff1995d
Route
topical
Published
Effective Date 2017-03-30
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 aloe vera leaf green tea leaf polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) xanthan gum edetate sodium sodium citrate citric acid monohydrate methylchloroisothiazolinone methylisothiazolinone fd&c green no. 3 d&c yellow no. 10

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-03-29
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Uses

For hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • Apply onto dry hands.
  • Lather and rinse thoroughly with water.
Other Information

Store at room temperature.

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Green 3 (CI 42053), Yellow 10 (Ci 47005).

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredients

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 for more than 72 hours.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only.

Uses

For hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • Apply onto dry hands.
  • Lather and rinse thoroughly with water.
Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Green 3 (CI 42053), Yellow 10 (Ci 47005).

Label Copy

Active Ingredients (Active ingredients)

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 for more than 72 hours.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:18.164338 · Updated: 2026-03-14T22:54:40.661795