Benzethonium chloride
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
- deep or puncture wounds
- animal bites
- serious burns
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
- 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
Mechanism of Action
There is limited information regarding Benzethonium chloride Mechanism of Action in the drug label.
Structure
Active Ingredients
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
{{#ask: Page Name::Benzethonium chloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
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)
Ingredients and Appearance
{{#ask: Label Page::Benzethonium chloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.