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TOLNAFTATE ANTIFUNGAL by Geri-Care Pharmaceuticals, Corp

Medically reviewed on January 25, 2018

Dosage form: powder
Ingredients: TOLNAFTATE 1g in 100g
Labeler: Geri-Care Pharmaceuticals, Corp
NDC Code: 57896-199

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.)

TOLNAFTATE ANTIFUNGAL 
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-199(NDC:75841-199)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TALC 
Packaging
#Item CodePackage Description
1NDC:57896-199-4545 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/01/2011
Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP Laboratories965480861manufacture(57896-199), relabel(57896-199)

 
Geri-Care Pharmaceuticals, Corp

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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