FDA Label for Tolnaftate Antifungal

View Indications, Usage & Precautions

Tolnaftate Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Geri-care Pharmaceuticals, Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



DRUG FACTS

TOLNAFTATE 1 PERCENT


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.)


* Please review the disclaimer below.