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  5. Label Information: Derman Antifungal Powder Tolnaftate

FDA Label for Derman Antifungal Powder Tolnaftate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABELING:

Derman Antifungal Powder Tolnaftate Product Label

The following document was submitted to the FDA by the labeler of this product Taisho Pharmaceutical California 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.

Active Ingredient



Tolnaftate 1%


Purpose



Antifungal


Uses



Proven clinically effective in the treatment of most:

  • Athlete's foot (tinea pedis) 
  • Jock itch (tine cruris)
  • Ringworm (tinea corporis)

    • Clinically proven to prevent most athlete's foot with daily use Relieves

    • itching 
    • cracking
    • burning
    • scaling

Warnings



For external use only

Flammable: Contents under pressure. Do not puncture or incinetare or store at a temperature above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or white smoking.


Do Not Use



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


When Using This Product



avoid contact with the eyes


Stop Use And Ask A Doctor



if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 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



  • clean the affected area and dry thoroughly
  • shake can well before use: hold can about 6 inches from the area to be treated
  • apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch
  • to prevent most athlete's foot apply once or twice daily (morning and/or night)
  • if condition persists longer, consult a doctor 
  • this product is not effective on the scalp or nails
  • 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

Other Information



store between 20° and 30°C (68° and 86°F)


Inactive Ingredients



BHT, Corn Starch, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B


Package Labeling:



Label - Label

Label - Label


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