Label: CANESPIES- tolnaftate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 26, 2022

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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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

    WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

  • 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
  • INACTIVE INGREDIENTS

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

  • OTHER INFORMATION

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

    0-LBL_Canespies Cream USP 1pct 0.5 oz

  • 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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    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 finalpart333C07/26/2022
    Labeler - OPMX LLC (029918743)
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