FDA.reportPublic FDA data

Tolnaftate

Manufacturer
NexMed (USA), Inc.
Effective date
2011-08-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:29:14

Label at a glance#

ProductTolnaftate D
Active ingredientTolnaftate
Label structure13 sections

Indications and uses

Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Proven effective in the prevention of athlete’s foot Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Dosage and administration

Clean the affected area and dry thoroughly Apply a thin layer over affected area twice a daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete’s foot, pay attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily For athlete’s foot and ringworm use daily for 4 weeks, for jock itch use daily for 2...

Storage and handling

Store between 20 ⁰ and 25 ⁰ C (68 ⁰ to 77 ⁰ F) Lot No. and Exp. Date: see box or see crimp of tube Keep box for complete instructions and labeling

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • Proven effective in the prevention of athlete’s foot
  • Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation occurs
  • There is no improvement within 2 weeks (for jock itch) and 4 weeks for (athlete’s foot and ringworm)

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age except under the advice and supervision of a doctor

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly
  • Apply a thin layer over affected area twice a daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete’s foot, pay attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • For athlete’s foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.
  • If condition persists longer consult a doctor
  • This product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • Store between 20⁰ and 25⁰C (68⁰ to 77⁰F)
  • Lot No. and Exp. Date: see box or see crimp of tube
  • Keep box for complete instructions and labeling

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cetyl  alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride, methylparaben, mineral oil, ceteth-10, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton labelImage of carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN4
103951tolnaftate 10 MG/ML Topical CreamSCD4
103951tolnaftate 1 % Topical CreamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40002-002-012019-10-29C16284748780-1960f7f55-c767-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40002-002-01TolnaftateD1 in 1 CARTONCREAM14
40002-002-02TolnaftateD28 g in 1 TUBECREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40002-002TOLNAFTATE D (TOLNAFTATE) CREAM [NEXMED (USA), INC.]4Legacy NDC, 2 package rows20110817_a09029b2-942e-479d-aa21-453d9a03f60e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKV4
TolnaftateACTIVE MOIETY06KB629TKV4
Ceteth-10INACTIVE INGREDIENTLF9X1PN3XJ4
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN4
Dodecyl-2-N,N-Dimethylaminopropionate HydrochlorideINACTIVE INGREDIENT18F5YMF9894
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T4
Mineral OilINACTIVE INGREDIENTT5L8T28FGP4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V34
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH4
Sorbitan MonostearateINACTIVE INGREDIENTNVZ4I0H58X4
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1Y4
WaterINACTIVE INGREDIENT059QF0KO0R4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40002-00240002-002-02, 40002-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Tolnaftate06KB629TKVACTIB
Cetyl Alcohol936JST6JCNIACT
Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride18F5YMF989IACT
MethylparabenA2I8C7HI9TIACT
Mineral OilT5L8T28FGPIACT
Ceteth-10LF9X1PN3XJIACT
Propylene Glycol6DC9Q167V3IACT
PropylparabenZ8IX2SC1OHIACT
Water059QF0KO0RIACT
Sorbitan MonostearateNVZ4I0H58XIACT
Stearyl Alcohol2KR89I4H1YIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 302 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
Stearyl AlcoholSTEARYL ALCOHOL2KR89I4H1YPOWDER / ORAL0.11 mgExact identifier — unii candidate
12 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPOWDER / ORALNAExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sorbitan MonostearateSORBITAN MONOSTEARATENVZ4I0H58XSOLUTION / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPASTE, DENTIFRICE / DENTAL0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
331f6703-c665-4168-ae6b-4e38d58905f9a09029b2-942e-479d-aa21-453d9a03f60e2011-08-16WarningsExact identifier
spl id: 331f6703-c665-4168-ae6b-4e38d58905f9
spl set id: a09029b2-942e-479d-aa21-453d9a03f60e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.