FDA Label for Fungisolve Tolnaftate Antifungal

View Indications, Usage & Precautions

Fungisolve Tolnaftate Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Dannso Corp./d.b.a. Essential Products. 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 Ingredients



Tolnaftate 1%



Purpose



Antifungal


Uses



cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)

can prevent recurrence of most athlete's foot

relieves sympotoms of athelete's foot including itching, burning, cracking and scaling.


Warnings



For external use only


Do Not Use



  • children under 2 years of age unless directed by a doctor
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

Stop Use And Ask A Doctor If



too much irritation occurs or irratation gets worse


When Using This Product



avoid contact with the eyes or mouth. If eye contacts occurs, rinse eyes thoroughtly with water.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center immediately.


Directions



  • adults and children 12 years and over
  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily morning and night
  • supervis children in the use of this product
  • for athlete's foot, pay special attention to spaces between the toes: wear well-fitting ventilated shoes and change shoes and socks at least once a day.

Other Information



store between 20 to 25 C (68 to 77)F

do not accept if safety seal is torn broken or missing.


Inactive Ingredients



Ceteareth-6, cety stearyl alcohol, methylparaben, mineral oil, PEG-20 cetyl/stearyl ether, propylene glycol, propylparaben, purified water, sodium m-bisulfite, stearyl alcohol.


Questions?



Call 305 2618762 M-F 9AM to 4PM Eastern Time


Distributed By:



Essential Productd Miami, FL, 33126 www.essentialproductsusa.com


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