drug facts

drug facts
SPL v1
SPL
SPL Set ID 813fe7e9-4ccb-4450-8c76-864f80aede94
Route
topical
Published
Effective Date 2016-02-05
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 citric acid monohydrate poloxamer 124 edetate sodium polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) 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 2016-02-03
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Purpose

Antibacterial

Directions

Squeeze a small amount onto a wet wash cloth, sponge, pouf or hands and apply to body. Work into a rich lather and rinse off.

Inactive Ingredients

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

Description

Benzalkonium Chloride 0.13%

Use

for washing to decrease bacteria on the skin.

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Questions Or Comments?

1-800-746-7287

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse 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 A Doctor If
  • irritation and redness develops.

Structured Label Content

Warnings

For external use only.

Purpose

Antibacterial

Directions

Squeeze a small amount onto a wet wash cloth, sponge, pouf or hands and apply to body. Work into a rich lather and rinse off.

Inactive Ingredients (Inactive ingredients)

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

Use

for washing to decrease bacteria on the skin.

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Questions Or Comments? (Questions or comments?)

1-800-746-7287

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:03.792400 · Updated: 2026-03-14T22:54:15.762833