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


Flammable



Do not use while smoking or near heat or flame.


Do Not Use



  • children under 2 years of age unless directed by a doctor

When Using This Product



  • avoid contact with the eyes or mouth, intentional misuse by deliberately concentrating and inhaling the content can be harmful or fatal.
  • use only as directed

Stop Use And Ask A Doctor If



  • irritation occurs
  • there is no improvement within 4 weeks (for athelete's foot and ringworm) or 2 weeks (for jock itch)

Keep Out Of Reach Of Children.



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


Directions



  • wash the affected area and dry thoroughtly
  • spray a thin layer over the 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.
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if the condiotion persists longer, ask a doctor
  • this product is not effective on scalp or nails

Other Information



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

Tamper evident do not accept if safety seal is broken or missing.


Inactive Ingredients



Aloe vera, alpha-tocopherol, franfrance, Isopropyl alcohol, Polyethylene Glycol, purified water, sodium m-bisulfite.


Questions Or Comments?



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


Distributed By:



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


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