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
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 onto wet hands, cloth or body sponge
  • work into a lather
  • wash skin and dry thoroughly
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%

Section 50567-7

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

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

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

Warnings

For external use only.

Uses

For washing to decrease bacteria on the skin.

Purpose

Antibacterial

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

Section 50567-7 (50567-7)

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

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

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