Benzethonium chloride: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag=<!--Overview-->{{RB}}
|OTC=Yes
|genericName=Benzethonium chloride and benzocaine
|aOrAn=a
|aOrAn=a
|hasBlackBoxWarning=Yes
|drugClass=OTC antiseptic
|adverseReactions=<!--Black Box Warning-->
|indicationType=treatment
|indication=first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns
|adverseReactions=Dry skin, redness
 
 
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
 


<!--Adult Indications and Dosage-->
<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
 
* first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns
* Dosing Information
 
:* Dosage


=====Condition2=====
====Directions====


* Dosing Information
* 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


:* Dosage
=====Condition3=====
* Dosing Information
:* Dosage
=====Condition4=====
* Dosing Information
:* Dosage
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


Line 113: Line 103:


<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|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


====Precautions====
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


* Description


<!--Adverse Reactions-->
<!--Adverse Reactions-->
Line 264: Line 269:


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|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


* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description
 


<!--IV Compatibility-->
<!--IV Compatibility-->
Line 296: Line 304:


<!--Structure-->
<!--Structure-->
|structure=*
|structure=====Active Ingredients====
 
: [[File:Benzethonium chloride act ing.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Inactive ingredients====


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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-->
<!--Pharmacodynamics-->
Line 314: Line 326:
<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|storage=
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
  *  store at 20-25°C (68-77°F)
  *  retain carton for future reference
 
|packLabel=PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
 
NDC 63824-810-01


<!--Precautions with Alcohol-->
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)
: [[File:Benzethonium chloride PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
 
: [[File:Benzethonium chloride Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
 
<!--Patient Counseling Information-->
|fdaPatientInfo=* Questions?
 
1-866-252-5327 FREE.
 
You may also report side effects to this phone number.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* LANACANE MAXIMUM STRENGTH ANTI-ITCH®<ref>{{Cite web | title = benzethonium chloride and benzocaine cream | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=96eb2dcc-4653-452a-9abd-fe92114a14ad}}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Revision as of 17:15, 4 February 2015

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]

Disclaimer

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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

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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)

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

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 Clinical Trial Experience of Benzethonium chloride in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

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

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

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

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)

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

{{#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.

  1. ↑ "benzethonium chloride and benzocaine cream".

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