FDA.reportPublic FDA data

CANESPIES

Manufacturer
HEALTH LIFE
Effective date
2019-04-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:28:24

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 - 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.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CETYL ALCOHOL, LIQUID PARAFFIN, METHYLPARABEN, POLYOXYETHYLNE CETYLETHER, PROPYLENE GLYCOL, PROPYLPARABEN, PURIFIED WATER, SORBITAN MONOSTEARATE, STEARYL ALCOHOL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0-LBL_Canespies Cream USP 1pct 0.5 oz0-LBL_Canespies Cream USP 1pct 0.5 oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-610-052023-10-22C16284748780-1ba0f9c33-57e1-a910-e053-dadaa90a0b8507e3f2ef-626f-4a7b-8e20-1bb2475522bb
69517-610-052021-01-29C16284748780-1ba0f9c33-57e1-a910-e053-dadaa90a0b8507e3f2ef-626f-4a7b-8e20-1bb2475522bb

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-61069517-610-01, 69517-610-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
CETYL ALCOHOL936JST6JCNIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
CETETH-10LF9X1PN3XJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARYL ALCOHOL2KR89I4H1YIACT

Source Document#

Source XML

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
0846edbf-bded-54c6-e063-6394a90a44c007e3f2ef-626f-4a7b-8e20-1bb2475522bb2023-10-21WarningsExact identifier
spl set id: 07e3f2ef-626f-4a7b-8e20-1bb2475522bb

Reported adverse events (FAERS/openFDA)#

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