Canespies Cream
FDA Label NDC 69729-610

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Canespies (NDC 69729-610). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, otc - when using, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

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

Otc - 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

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