TOLNAFTATE ANTIFUNGAL- tolnaftate powder

TOLNAFTATE ANTIFUNGAL by

Drug Labeling and Warnings

TOLNAFTATE ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceuticals, Corp, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.)

INGREDIENTS AND APPEARANCE

TOLNAFTATE ANTIFUNGAL 
tolnaftate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-199(NDC: 75841-199)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-199-45	45 g in 1 BOTTLE, DISPENSING; Type 7: Separate Products Requiring Cross Labeling	08/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/01/2011

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(57896-199) , relabel(57896-199)