SPL v1
SPL
SPL Set ID a501d01d-a3ff-10aa-e053-2a95a90aa7e0
Route
TOPICAL
Published
Effective Date 2020-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (2 mg)
Inactive Ingredients
Hydroxymethyl Cellulose Cocamine Oxide Hydrogenated Starch Hydrolysate Undeceth-7 Water Anhydrous Citric Acid Sodium Hydroxide Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-02
Description

Benzethonium chloride, 0.2% w/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzethonium chloride, 0.2% w/v

Use

For handwashing to decrease bacteria on skin.

Warning

For external use only.

Directions
  • Hands need not be washed prior to using.
  • For one step hand wash/antiseptic skin cleaning.
  • Place 5 milliliters in palm of hand, add water, work up a lather and scrub for 30 seconds.
  • Rinse hands thoroughly with potable water after washing.
Active Ingredient

Benzethonium chloride, 0.2% w/v

Inactive Ingredients

Citric acid; 1,3-Dihydroxymethyl-5,5-dimethylhydantoin and 3-iodo-2-propynyl butyl carbamate; Ethoxylated C11 Alcohol; Hydrogenated starch hydrolysate; Hydroxypropyl methylcellulose; N-alkykl (C12-C16)-N, N-dimethylamine oxide; Sodium hydroxide; Water.

Questions Or Comments?

320-693-2477

Principal Display Panel

When Using This Product
  • discontinue use if irritatio and redness develop.
  • do not use in or near eyes.
Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation or redness develops, or if conditions persist for more than 72 hours.

Keep Out of Reach of Children.

Keep out of reach of children, except under adult supervision.

  • In case of accidental ingestion, see medical attention or contact a poision control cernter immediately.

Structured Label Content

Use

For handwashing to decrease bacteria on skin.

Purpose

Antiseptic

Warning

For external use only.

Directions
  • Hands need not be washed prior to using.
  • For one step hand wash/antiseptic skin cleaning.
  • Place 5 milliliters in palm of hand, add water, work up a lather and scrub for 30 seconds.
  • Rinse hands thoroughly with potable water after washing.
Active Ingredient (Active ingredient)

Benzethonium chloride, 0.2% w/v

Inactive Ingredients (Inactive ingredients)

Citric acid; 1,3-Dihydroxymethyl-5,5-dimethylhydantoin and 3-iodo-2-propynyl butyl carbamate; Ethoxylated C11 Alcohol; Hydrogenated starch hydrolysate; Hydroxypropyl methylcellulose; N-alkykl (C12-C16)-N, N-dimethylamine oxide; Sodium hydroxide; Water.

Questions Or Comments? (Questions or comments?)

320-693-2477

Principal Display Panel

When Using This Product (When using this product)
  • discontinue use if irritatio and redness develop.
  • do not use in or near eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if irritation or redness develops, or if conditions persist for more than 72 hours.

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

Keep out of reach of children, except under adult supervision.

  • In case of accidental ingestion, see medical attention or contact a poision control cernter immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:50.625437 · Updated: 2026-03-14T22:58:36.589882