FDA.reportPublic FDA data

CANESPIES

Manufacturer
OPMX LLC
Effective date
2024-05-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:45

Label at a glance#

ProductCANESPIES
Active ingredientTOLNAFTATE
Label structure10 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

WASH AFFECTED AREA AND DRY THOROUGHLY APPLY A THIN LAYER OVER AFFECTED AREA TWICE DAILY (MORNING AND NIGHT) OR AS DIRECTED BY A DOCTOR SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT FOR ATHLETE'S FOOT, PAY SPECIAL ATTENTION TO SPACES BETWEEN THE TOES, WEAR WELL-FITTING, VENTILLATED 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 FO...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

TOLNAFTATE 1%

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.

STOP USE AND ASK A DOCTOR IF

IRRITATION OCCURS

THERE IS NO IMPROVEMENT WITHIN 4 WEEKS.

DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE EXCEPT UNDER THE ADVICE AND SUPERVISION OF A DOCTOR.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

  • If swallowed get medical help or contact Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • WASH AFFECTED AREA AND DRY THOROUGHLY
  • APPLY A THIN LAYER OVER AFFECTED AREA TWICE DAILY (MORNING AND NIGHT) OR AS DIRECTED BY A DOCTOR
  • SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT FOR ATHLETE'S FOOT, PAY SPECIAL ATTENTION TO SPACES BETWEEN THE TOES, WEAR WELL-FITTING, VENTILLATED 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 WEKS. IF CONDITION PERSISTS LONGER CONSULT A DOCTOR
  • THIS PRODUCT IS NOT EFFECTIVE ON THE SCALP OR NAILS

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • STORE AT 15° TO 30°C (59°F TO 86°F)
  • LOT NO. & EXP. DATE: SEE BOX OR CRIMP OF TUBE

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CETETH-20, CETYL ALCOHOL, CHLOROCRESOL, MINERAL OIL, PROPYLENE GLYCOL, SODIUM PHOSPHATE MONOBASIC, WHITE SOFT PARAFFIN, PURIFIED WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-610-05

CC1CC1CC2CC2

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
69729-610-052024-05-20C16284748780-19d75b9d0-382c-f424-e053-dadaa90a57cee2f9eedc-3c43-416b-85b5-ba07fb5fb4db
69729-610-052024-01-30C16284748780-19d75b9d0-382c-f424-e053-dadaa90a57cee2f9eedc-3c43-416b-85b5-ba07fb5fb4db
69729-610-052022-07-27C16284748780-19d75b9d0-382c-f424-e053-dadaa90a57cee2f9eedc-3c43-416b-85b5-ba07fb5fb4db
69729-610-052020-01-31C16284748780-19d75b9d0-382c-f424-e053-dadaa90a57cee2f9eedc-3c43-416b-85b5-ba07fb5fb4db

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-610-01CANESPIES14 g in 1 TUBECREAM144
69729-610-05CANESPIES1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-610CANESPIES (TOLNAFTATE) CREAM [OPMX LLC]4Current NDC, Legacy NDC, 2 package rows20240521_e2f9eedc-3c43-416b-85b5-ba07fb5fb4db.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-61069729-610-01, 69729-610-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
CETETH-20I835H2IHHXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
TOLNAFTATE06KB629TKVACTIB
CHLOROCRESOL36W53O7109IACT

Source Document#

Source XML · Source PDF

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
CANESPIESTOLNAFTATEOPMX LLCe2f9eedc-3c43-416b-85b5-ba07fb5fb4db2024-05-17WarningsExact identifier
ndc (package): 69729-610-01
ndc (package): 69729-610-05
ndc (product): 69729-610
ndc11 (package): 69729061005
ndc11 (package): 69729061001
spl id: 18af4a4a-82b5-da15-e063-6394a90a56da
spl set id: e2f9eedc-3c43-416b-85b5-ba07fb5fb4db

Reported adverse events (FAERS/openFDA)#

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