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{{Drugbox|
{{DrugProjectFormSinglePage
|IUPAC_name = ''O''-(2-naphthyl) methyl(3-methylphenyl)thiocarbamate
|authorTag={{RB}}
| image=Tolnaftate.svg
|OTC=Yes
| CAS_number= 2398-96-1  
|genericName=Tolnaftate
| ATC_prefix=D01
|aOrAn=a
| ATC_suffix=AE18  
|drugClass=OTC antifungal
| ATC_supplemental=
|indicationType=treatment
| PubChem=5510
|indication=[[athlete’s foot]] ([[tinea pedis]]), [[ringworm]] ([[tinea corporis]])
| DrugBank=
|adverseReactions=[[irritation]]
| C = 19 | H = 17 | N = 1 | O = 1 | S = 1
 
 
 
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=====Indications====
* [[athlete’s foot]] ([[tinea pedis]])
* [[ringworm]] ([[tinea corporis]])
: helps prevent most athlete’s foot with daily use
* for effective relief of itching, burning, cracking
 
====Directions====
* wash affected area and dry thoroughly
* apply a thin layer over affected area twice daily (morning and night)
* supervise children in the use of this product
* for athlete’s foot: pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
* use daily for 4 weeks. If condition lasts longer, ask a doctor.
* to prevent athlete’s foot, apply once or twice daily (morning and/or night)
* this product is not effective on the scalp or nails
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=* Onychomycosis due to dermatophyte<ref name="pmid6228447">{{cite journal| author=Ishii M, Hamada T, Asai Y| title=Treatment of onychomycosis by ODT therapy with 20% urea ointment and 2% tolnaftate ointment. | journal=Dermatologica | year= 1983 | volume= 167 | issue= 5 | pages= 273-9 | pmid=6228447 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=6228447  }} </ref>
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=<!--Warnings-->
|warnings=* For external use only
 
=====When using this product=====
* avoid contact with the eyes
 
=====Stop use and ask a doctor if=====
:* irritation occurs
:* there is no improvement within 4 weeks
=====Do not use=====
* children under 2 years of age unless directed by a doctor
 
=====Keep out of reach of children=====
* If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=* [[irritation]]
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|drugInteractions=<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Topical cream
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
 
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox={{Drugbox2
| Verifiedfields = changed
| verifiedrevid = 470611568
| IUPAC_name = ''O''-2-naphthyl methyl(3-methylphenyl)thiocarbamate
| image = Tolnaftate Wiki str.png
 
<!--Clinical data-->
| tradename = Tinactin
| Drugs.com = {{drugs.com|monograph|tolnaftate}}
| MedlinePlus = a682617
| pregnancy_category = 
| legal_status = OTC
| routes_of_administration =
 
<!--Pharmacokinetic data-->
| bioavailability = 
| metabolism = 
| excretion =
 
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 2398-96-1
| ATC_prefix = D01
| ATC_suffix = AE18
| PubChem = 5510
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00525
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 5309
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 06KB629TKV
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D00381
| ChEBI_Ref = {{ebicite|changed|EBI}}
| ChEBI = 9620
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 83668
 
<!--Chemical data-->
| C=19 | H=17 | N=1 | O=1 | S=1  
| molecular_weight = 307.41 g/mol
| molecular_weight = 307.41 g/mol
| bioavailability=  
| smiles = S=C(Oc2ccc1c(cccc1)c2)N(c3cc(ccc3)C)C
| metabolism =  
| InChI = 1/C19H17NOS/c1-14-6-5-9-17(12-14)20(2)19(22)21-18-11-10-15-7-3-4-8-16(15)13-18/h3-13H,1-2H3
| elimination_half-life=
| InChIKey = FUSNMLFNXJSCDI-UHFFFAOYAF
| excretion =
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| pregnancy_category =  
| StdInChI = 1S/C19H17NOS/c1-14-6-5-9-17(12-14)20(2)19(22)21-18-11-10-15-7-3-4-8-16(15)13-18/h3-13H,1-2H3
| legal_status =  
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| routes_of_administration=  
| StdInChIKey = FUSNMLFNXJSCDI-UHFFFAOYSA-N
| melting_point = 110
| melting_high = 111.5
}}
}}
'''Tolnaftate''' is a synthetic [[over-the-counter_drug|over-the-counter]] [[anti-fungal]] agent. It may come as a cream, powder, spray, or [[liquid aerosol]], and is used to treat [[jock itch]], [[athlete's foot]] and [[ringworm]].  It is sold under several brand names, most notably '''Tinactin''' ([[Schering-Plough|Schering-Plough Corporation]]) and '''[[Odor Eaters]]''' ([[Combe Incorporated]]). Other brands are Absorbine, Aftate, [[Desenex]], Genaspor, NP 27, Scholl and Ting.


==External links==
*[http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682617.html Medline's entry for tolnaftate]


{{Antifungals}}
 
{{antimicrobial-stub}}
<!--Mechanism of Action-->
[[Category:Antifungals]]
|mechAction=
{{WikiDoc Sources}}
 
<!--Structure-->
|structure=
 
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|howSupplied=
|storage=* store at 68°-77°F (20°-25°C)
|packLabel=====PRINCIPAL DISPLAY PANEL====
Cures Most Athlete’s Foot
 
Relieves Itching & Burning
 
Compare to Tinactin® active ingredient
 
Tolnaftate Cream USP, 1%
 
Antifungal
 
: [[File:Tolnaftate PDP.png|thumb|none|500px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
 
: [[File:Tolnaftate Ing and App.png|thumb|none|500px|This image is provided by the National Library of Medicine.]]
 
 
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
|brandNames=* Tinactin®<ref>{{Cite web | title = Tolnaftate | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d277ed85-8ee7-46e2-a575-5b363d3d9185}}</ref>
 
<!--Look-Alike Drug Names-->
|lookAlike=<!--Drug Shortage Status-->
|drugShortage=
}}
<!--Pill Image-->
 
 
 
<!--Label Display Image-->
 
 
 
 
 
<!--Category-->
 
[[Category:Drug]]

Latest revision as of 17:18, 20 August 2015

Tolnaftate
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

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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

Tolnaftate is a OTC antifungal that is FDA approved for the treatment of athlete’s foot (tinea pedis), ringworm (tinea corporis). Common adverse reactions include irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

helps prevent most athlete’s foot with daily use
  • for effective relief of itching, burning, cracking

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot: pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • use daily for 4 weeks. If condition lasts longer, ask a doctor.
  • to prevent athlete’s foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

  • Onychomycosis due to dermatophyte[1]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Tolnaftate Contraindications in the drug label.

Warnings

  • For external use only
When using this product
  • avoid contact with the eyes
Stop use and ask a doctor if
  • irritation occurs
  • there is no improvement within 4 weeks
Do not use
  • children under 2 years of age unless directed by a doctor
Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Tolnaftate 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 Tolnaftate in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Topical cream

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Overdose of Tolnaftate in the drug label.

Pharmacology

Template:Px
Tolnaftate
Systematic (IUPAC) name
O-2-naphthyl methyl(3-methylphenyl)thiocarbamate
Identifiers
CAS number 2398-96-1
ATC code D01AE18
PubChem 5510
DrugBank DB00525
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 307.41 g/mol
SMILES eMolecules & PubChem
Physical data
Melt. point 110–111.5 °C (230–233 °F)
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status

OTC

Routes ?

Mechanism of Action

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

Structure

There is limited information regarding Tolnaftate Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

  • store at 68°-77°F (20°-25°C)

Images

Drug Images

{{#ask: Page Name::Tolnaftate |?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

Cures Most Athlete’s Foot

Relieves Itching & Burning

Compare to Tinactin® active ingredient

Tolnaftate Cream USP, 1%

Antifungal

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::Tolnaftate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Tolnaftate in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

There is limited information regarding Tolnaftate 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. ↑ Ishii M, Hamada T, Asai Y (1983). "Treatment of onychomycosis by ODT therapy with 20% urea ointment and 2% tolnaftate ointment". Dermatologica. 167 (5): 273–9. PMID 6228447.
  2. ↑ "Tolnaftate".
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