FDA Label for Tinactin

View Indications, Usage & Precautions

Tinactin Product Label

The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. 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.

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Drug Facts

Distributed by

Bayer HealthCare LLC, Whippany, NJ, USA, 07981


Active Ingredient



Tolnaftate 1%


Purpose



Antifungal


Uses



  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking

Warnings



For external use only


Otc - When Using



When using this product avoid contact with the eyes


Stop Use And Ask A Doctor If



  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Do Not Use



Do not use on children under 2 years of age except under the advice and supervision of a doctor.


Otc - 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.


Directions



  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise 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 daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Other Information



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


Inactive Ingredients



ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum


Questions?



1-866-360-3266


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