drug facts

drug facts
SPL v1
SPL
SPL Set ID c03fad9d-3703-44ed-aa2e-7c3c2d6b97fe
Route
topical
Published
Effective Date 2020-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.0 mg)
Inactive Ingredients
water polysorbate 20 ppg-26-buteth-26 polyoxyl 40 hydrogenated castor oil aloe vera leaf green tea leaf dmdm hydantoin fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-04-14
Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%

Medication Information

Warnings

For external use only.

Uses

to help decrease bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Directions
  • pump enough product to your palm to thoroughly cover your hands, rub together for at least 30 seconds, until dry.
  • children under 6 years should be supervised when using this product.
Other Information

store at room temperature.

Inactive Ingredients

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

Description

Benzalkonium Chloride 0.1%

Labe Copy

Do Not Use
  • on children less than 2 months of age
  • on open wounds
Active Ingredient

Benzalkonium Chloride 0.1%

Questions Or Comments?

1-866-695-3030

When Using This Product

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

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 or redness develops and lasts more than 7 days.

Structured Label Content

Warnings

For external use only.

Uses

to help decrease bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Directions
  • pump enough product to your palm to thoroughly cover your hands, rub together for at least 30 seconds, until dry.
  • children under 6 years should be supervised when using this product.
Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

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

Labe Copy

Do Not Use (Do not use)
  • on children less than 2 months of age
  • on open wounds
Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.1%

Questions Or Comments? (Questions or comments?)

1-866-695-3030

When Using This Product (When using this product)

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

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 or redness develops and lasts more than 7 days.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:13.724233 · Updated: 2026-03-14T22:56:14.192854