Active Ingredient
DRUG FACTS
TOLNAFTATE 1 PERCENT
Tolnaftate Antifungal Powder
FDA Label NDC 57896-199
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Tolnaftate Antifungal (NDC 57896-199). 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 ingredient, purpose section, keep out of reach of children, indications and uses section, warnings section, dosage and administration section, inactive ingredients section, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose Section
ANTIFUNGAL
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Indications And Uses Section
USES
FOR EFFECTIVE TREATMENT OF MOST ATHLETE'S FOOT(LINEA PEDIS) AND RING WORM (THEA CORPORIS)
FOR EFFECTIVE RELIEF OF ITCHY, SCALY SKIN BETWEEN THE TOES
CLEARS UP MOST ATHLETE'S FOOT INFECTION AND WITH DAILY USE HELPS KEEP IT FROM COMING BACK
Warnings Section
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE EXCEPT UNDER THE ADVICE AND SUPERVISION OF A DOCTOR.
WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES
STOP USE AND CONSULT A DOCTOR IF IRRITATION OCCURS THERE IS NO IMPROVEMENT WITHIN 4 WEEKS
OTHER INFORMATION
STORE AT ROOM TEMPERATURE
Dosage And Administration Section
DRUG FACTS
DIRECTIONS
SHAKE WELL BEFORE USE CLEAN THE AFFECTED AREA AND DRY THOROUGHLY APPLY A THIN LAYER OF THE PRODUCT OVER AFFECTED AREA TWICE DAILY (MORNING AND NIGHT) OR AS DIRECTED BY A DOCTOR SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT USE DAILY FOR 4 WEEKS. IF CONDITION PERSISTS LONGER, CONSULT A DOCTOR
FOR ATHLETE'S FOOT
PAY SPECIAL ATTENTION TO THE SPACES BETWEEN THE TOES WEAR WELL VENTILATED SHOES CHANGE SHOES AND SOCKS AT LEAST ONCE A DAY TO PREVENT ATHLETE'S FOOT, CLEAN AND DRY FEET THOROUGHLY. APPLY AS ABOVE ONCE OR TWICE DAILY.
THIS PRODUCT IS NOT EFFECTIVE ON THE SCALP OR NAILS.
Inactive Ingredients Section
CORN STARCH AND TALC
Package Label
NDC 57896-199-45 GERICARE TOLNAFTATE ANTIFUNGAL POWDER 1 PERCENT
CURES AND PREVENTS MOST ATHLETE'S FOOT
COMPARE TO THE ACTIVE INGREDIENT OF TINACTIN THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY THE OWNER OF THE REGISTERED TRADEMARK TINACTIN DISTRIBUTED BY GERI-CARE PHARMACEUTICALS 1650 63RD STREET BROOKLYN NY 11204 REV. 11/10 310-29009-0
NET WT. 45G (1 1/2 OZ.)
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