9a6f9047-aa6f-408d-abea-d367273ec154

SPL v1
SPL
SPL Set ID 9a6f9047-aa6f-408d-abea-d367273ec154
Route
topical
Published
Effective Date 2017-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cocamidopropyl betaine glycerin decyl glucoside hydroxyethyl cellulose (5000 cps at 1%) aloe vera leaf polyoxyl 40 hydrogenated castor oil polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) edetate sodium citric acid monohydrate sodium citrate methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-04-11
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Uses

helps eliminate bacteria on hands.

Purpose

Antibacterial

Directions
  • apply onto wet hands.
  • lather and rinse thoroughly.
Other Information

store at room temperature.

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Glyceirn, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

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 and lasts.

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

helps eliminate bacteria on hands.

Purpose

Antibacterial

Directions
  • apply onto wet hands.
  • lather and rinse thoroughly.
Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Glyceirn, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Polyquaternium-7, Tetrasodium EDTA, Citric Acid, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

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 and lasts.

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: 2026-02-15T11:56:18.253397 · Updated: 2026-03-14T22:54:41.714370