Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b2beed06-ee8c-4f26-9afe-cc8b3b179a37
Route
TOPICAL
Published
Effective Date 2020-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Hypromelloses Edetate Sodium Citric Acid Monohydrate Sodium Hydroxide Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-16
Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Uses

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

Warnings

For external use only.

Directions
  • put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry.
  • Children under 6 years should be supervised when using this product.
Do Not Use
  • on children less than 2 months of age
  • on open skin wounds
Label Copy

Questions?

1-866-695-3030

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

When Using This Product

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

Stop Use and Ask A Doctor If

irritation develops.

Keep Out of Reach of Children.

If swallowed, call or contact a Poison Control Center or get medical help right away.

Structured Label Content

Uses

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

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry.
  • Children under 6 years should be supervised when using this product.
Do Not Use (Do not use)
  • on children less than 2 months of age
  • on open skin wounds
Label Copy (Label copy)

Questions?

1-866-695-3030

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

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 develops.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call or contact a Poison Control Center or get medical help right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:14.225409 · Updated: 2026-03-14T22:57:40.950905