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 Cardinal Health 110,inc.. 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


Active Ingredient



Tolnaftate USP 1%


Purpose



Antifungal Cream


Uses



  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • Relieves the  itching, irratation, redness, scaling and discomfort which can accompany these conditions.

Warnings



  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only avoid contact with eyes.
  • Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).

Directions



  • 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 the spaces between the toes.
    • Wear well fitting ventilated shoes.
    • Change shoes and socks at least once daily.
    • For athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks.
    • If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.

Other Information



  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tighty after ever use.

Inactive Ingredients



Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water


Questions?



1-800-222-1222


Principal Display Panel – 1.0 Oz Tube



LEADER                  NDC 70000-0494-1

Compare to Tinactin 

CURES Most:

ATHLETE'S FOOT

                              Net Wt. 1.0 OZ (28 g)


Principal Display Panel – 1.0 Oz Carton



 LEADER          NDC 70000-0494-1

Antifungal Cream (Tolnaftate 1%) 

CURES Most:

ATHLETE'S FOOT

                                      Net Wt. 1.0 OZ (28 g)


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