Benzethonium chloride

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Benzethonium chloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Benzethonium chloride is a OTC antiseptic that is FDA approved for the treatment of first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns. Common adverse reactions include Dry skin, redness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns

Directions

  • adults and children 2 years of age and older: clean the affected area and apply a small amount to the affected area not more than 1 to 3 times daily
  • children under 2 years of age: ask a doctor
  • may be covered with a sterile bandage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Benzethonium chloride in adult patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzethonium chloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • There is limited information regarding FDA-Labeled Use of Benzethonium chloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Benzethonium chloride in pediatric patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzethonium chloride in pediatric patients.

Contraindications

There is limited information regarding Benzethonium chloride Contraindications in the drug label.

Warnings

For external use only
  • Do not use
  • in the eyes
  • over large areas of the body
Ask a doctor before use if you have
Stop use and ask a doctor if
  • condition worsens
  • needed for longer than 1 week
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Benzethonium chloride Clinical Trials Experience in the drug label.

Postmarketing Experience

  • There is limited information regarding Postmarketing Experience of Benzethonium chloride in the drug label.

Drug Interactions

There is limited information regarding Benzethonium chloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Benzethonium chloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Benzethonium chloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Benzethonium chloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Benzethonium chloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Benzethonium chloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Benzethonium chloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Benzethonium chloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Benzethonium chloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Benzethonium chloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Benzethonium chloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Benzethonium chloride in patients who are immunocompromised.

Administration and Monitoring

Administration

Directions

  • adults and children 2 years of age and older: clean the affected area and apply a small amount to the affected area not more than 1 to 3 times daily
  • children under 2 years of age: ask a doctor
  • may be covered with a sterile bandage

Monitoring

There is limited information regarding Monitoring of Benzethonium chloride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Benzethonium chloride in the drug label.

Overdosage

  • There is limited information regarding Overdose of Benzethonium chloride in the drug label.

Pharmacology

This image is privided by Wikipedia

Mechanism of Action

There is limited information regarding Benzethonium chloride Mechanism of Action in the drug label.

Structure

Active Ingredients

This image is provided by the National Library of Medicine.

Inactive ingredients

acetylated lanolin alcohol, aloe, cetyl acetate, cetyl alcohol, cholecalciferol, corn oil, dimethicone, dl-alpha tocopherol acetate, fragrance, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, mineral oil, PEG-100 stearate, polyvinylpyrrolidone/eicosene copolymer, propylparaben, pyrithione zinc, retinyl palmitate, sorbitan monostearate, stearamidopropyl PG-dimonium chloride phosphate, water

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Benzethonium chloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Benzethonium chloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Benzethonium chloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Benzethonium chloride in the drug label.

How Supplied

There is limited information regarding Benzethonium chloride How Supplied in the drug label.

Storage

  • store at 20-25°C (68-77°F)
  • retain carton for future reference

Images

Drug Images

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC 63824-810-01

LANACANE®

Maximum Strength

ANTI-ITCH CREAM

Benzethonium chloride 0.2% (First-Aid Antiseptic) Benzocaine 20% (Pain Relief Cream)

2-in-1

FAST Acting Itch Relief

+

Kills Germs*

  • unlike Hydrocortisones

Itch Relief from:

   Insect bites
   Rashes
   Dry, Itchy skin

NET WT 1 OZ (28 g)

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

Patient Counseling Information

  • Questions?
1-866-252-5327 FREE.
  • You may also report side effects to this phone number.

Precautions with Alcohol

  • Alcohol-Benzethonium chloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • LANACANE MAXIMUM STRENGTH ANTI-ITCH®[1]

Look-Alike Drug Names

There is limited information regarding Benzethonium chloride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. "benzethonium chloride and benzocaine cream".

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