208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa5

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

Purpose

Antibacterial

Description

Benzethonium Chloride 0.1%


Medication Information

Warnings

For external use only.

Uses

for washing to decrease bacteria on the skin.

Purpose

Antibacterial

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

Description

Benzethonium Chloride 0.1%

Section 51945-4

Active Ingredient

Benzethonium Chloride 0.1%

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

Warnings

For external use only.

Uses

for washing to decrease bacteria on the skin.

Purpose

Antibacterial

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

Section 51945-4 (51945-4)

Active Ingredient

Benzethonium Chloride 0.1%

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

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