Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 401106d1-a701-48bf-b8fc-1bc0454c4139
Route
TOPICAL
Published
Effective Date 2018-07-26
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 2018-07-25
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.

Section 50567-7

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

Warnings

For external use only.

Directions
  • squeeze onto wet hands, cloth or body sponge
  • work into a lather
  • wash skin and dry thoroughly
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).

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 develop.

Structured Label Content

Uses

For washing to decrease bacteria on the skin.

Section 50567-7 (50567-7)

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

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • squeeze onto wet hands, cloth or body sponge
  • work into a lather
  • wash skin and dry thoroughly
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).

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 develop.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:36.881961 · Updated: 2026-03-14T22:55:12.436150