Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2ca9d98d-ac29-4872-8e97-3c46f274199c
Route
TOPICAL
Published
Effective Date 2020-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Water Polysorbate 20 Octinoxate Avobenzone Octisalate Ppg-26-buteth-26 Polyoxyl 40 Hydrogenated Castor Oil Aloe Vera Leaf Green Tea Leaf Dmdm Hydantoin Sodium Hydroxide Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-20
Description

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%

Uses

to help decrease bacteria on the skin.

Warnings

For external use only

Directions
  • Pump enough product on your palm to thoroughly cover your hands, rub together until dry.
  • Children under 6 years should be supervised when using this product.
Label Copy

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Water (Aqua), Polysorbate 20, Ethylhexyl Methoxycinnamate, Buty Methoxydibenzoylmethane, Ethylhexyl Salicyalte, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Camellia Sinensis Leaf Extract, DMDM Hydantoin, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

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

Uses

to help decrease bacteria on the skin.

Purpose

Antiseptic

Warnings

For external use only

Directions
  • Pump enough product on your palm to thoroughly cover your hands, rub together until dry.
  • Children under 6 years should be supervised when using this product.
Label Copy (Label copy)

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.1%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Polysorbate 20, Ethylhexyl Methoxycinnamate, Buty Methoxydibenzoylmethane, Ethylhexyl Salicyalte, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Camellia Sinensis Leaf Extract, DMDM Hydantoin, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

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: 2026-02-15T11:57:05.051621 · Updated: 2026-03-14T22:55:59.360416