Label: CANESPIES- tolnaftate cream

  • NDC Code(s): 69729-610-01, 69729-610-05
  • Packager: OPMX LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 17, 2024

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  • ACTIVE INGREDIENTS

    TOLNAFTATE 1%

  • PURPOSE

    ANTIFUNGAL

  • 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

  • WARNINGS

    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.

  • WHEN USING

    WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

    • 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

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

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

  • PRINCIPAL DISPLAY PANEL

    NDC 69729-610-05

    CC1CC2

  • INGREDIENTS AND APPEARANCE
    CANESPIES 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CETETH-20 (UNII: I835H2IHHX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-610-051 in 1 BOX07/26/2022
    1NDC:69729-610-0114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00507/26/2022
    Labeler - OPMX LLC (029918743)
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