FDA Label for Tolnaftate

View Indications, Usage & Precautions

Tolnaftate Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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



Tolnaftate 1% w/w


​Purpose



Antifungal


Uses



proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corportis)

prevents the recurrences of athlete's foot with daily use

for effective relief of itching, burning, cracking, redness and scaling


Warnings



For external use only.


Do Not Use



on children 2 years of age unless directed by a doctor.


When Using This Product



avoid contact with eyes.


Stop Use And Consult A Doctor If



  • irritation occurs
  • there is no improvement in 4 weeks

Keep Out Of Reach Of Children.



If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.


​Directions



Read all warnings and directions. Use only as directed.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between toes
  • wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor
  • to prevent athlete's foot: wash the feet thoroughly, apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

​Other Information​



  • store at room temperature 15°-30°C (59° - 86°F)
  • protect from freezing. If freezing occurs warm to room temperature
  • keep tightly closed when not in use

​Inactive Ingredient



Water, Acrylates Copolymer, Glycerin (RSPO). Phenoxyethanol, Tocopherol, Sodium Hydroxide, Ethylhexyglycerin


Questions?



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