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
Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Uses

for washing to decrease bacteria on the skin.

Warnings

For external use only.

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

Active Ingredient

Benzalkonium chloride 0.13%

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).

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

Uses

for washing to decrease bacteria on the skin.

Purpose

Antibacterial

Warnings

For external use only.

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

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

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