SPL v167
SPL
SPL Set ID 208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa5
Route
TOPICAL
Published
Effective Date 2024-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (0.1 g)
Inactive Ingredients
Water Palm Acid Sodium Chloride Coconut Acid Sodium Palmate Sodium Cocoate Sodium Palm Kernelate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-04
Description

Benzethonium Chloride 0.1%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzethonium Chloride 0.1%

Uses

for washing to decrease bacteria on the skin.

Section 51945-4

Warnings

For external use only.

Directions
  • wet bar with water
  • lather vigorously and wash skin
  • rinse and dry thoroughly.
Active Ingredient

Benzethonium Chloride 0.1%

Inactive Ingredients

Soap (Sodium Palmate and/or Sodium Tallowate, Sodium Cocoate and/or Sodium Palm Kernelate), Water, Palm Acid, Glycerin, Sodium Chloride, Coconut Acid, Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous

When Using This Product

Avoid contact with eyes. In case of eye contact, flush with water.

Don't use this product on infants under 6 months of age.

Stop Use and Ask A Doctor

If irritation and redness develops.

Keep Out of Reach of Children.

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

Structured Label Content

Uses

for washing to decrease bacteria on the skin.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • wet bar with water
  • lather vigorously and wash skin
  • rinse and dry thoroughly.
Active Ingredient

Benzethonium Chloride 0.1%

Inactive Ingredients

Soap (Sodium Palmate and/or Sodium Tallowate, Sodium Cocoate and/or Sodium Palm Kernelate), Water, Palm Acid, Glycerin, Sodium Chloride, Coconut Acid, Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous

When Using This Product (When using this product)

Avoid contact with eyes. In case of eye contact, flush with water.

Don't use this product on infants under 6 months of age.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If irritation and redness develops.

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:36.032820 · Updated: 2026-03-14T23:05:28.061539