drug facts

drug facts
SPL v1
SPL
SPL Set ID 47b6c7f4-a479-4415-a0bc-351d06641f78
Route
topical
Published
Effective Date 2016-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cocamidopropyl betaine decyl glucoside hydroxyethyl cellulose (5000 cps at 1%) glycerin poloxamer 124 edetate sodium polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) citric acid monohydrate sodium citrate aloe vera leaf methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 ext. d&c violet no. 2

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-08-07
Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Medication Information

Warnings

For external use only.

Uses

for washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • Squeeze a small amount onto a wet washcloth, sponge, pouf or hand and apply to body.
  • work into rich lather and rinse off.
Other Information

store at room temperature.

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Decyl Glucoside, Hydroxyethylcellulose, Glycerin, Poloxamer 124, Fragrance (Parfum), Tetrasodium EDTA, Polyquaternium-7, Citric Acid, Sodium Citrate, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

Description

Benzalkonium chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium chloride 0.13%

Questions Or Comments?

1-866-665-3030

When Using This Product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If

irritation or redness develops.

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

for washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • Squeeze a small amount onto a wet washcloth, sponge, pouf or hand and apply to body.
  • work into rich lather and rinse off.
Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Decyl Glucoside, Hydroxyethylcellulose, Glycerin, Poloxamer 124, Fragrance (Parfum), Tetrasodium EDTA, Polyquaternium-7, Citric Acid, Sodium Citrate, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Questions Or Comments? (Questions or comments?)

1-866-665-3030

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or redness develops.

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:09.189657 · Updated: 2026-03-14T22:54:23.335310