Active Ingredients
TOLNAFTATE 1%
Canespies Cream
FDA Label NDC 69729-610
10 label sections · Submitted to the FDA by Opmx Llc · 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 - when using, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 - When Using
WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.
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.
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
Package Label.Principal Display Panel
NDC 69729-610-05
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