Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 272ba05c-22eb-43a9-964b-359012f67aab
Route
TOPICAL
Published
Effective Date 2020-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Hydroxypropyl Guar (2500-4500 Mpa.s At 1%) Edetate Sodium Citric Acid Monohydrate Sodium Hydroxide Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-14
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.
Label Copy

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

Benzalkonium Chloride 0.13%

Inactive Ingredients

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

Questions Or Comments?

1-866-695-3030

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 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.
Label Copy (Label copy)

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

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

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

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 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 a Poison Control Center or get medical help right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:13.601996 · Updated: 2026-03-14T22:56:12.801840