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  5. Label Information: First Aid Antifungal Medicated

FDA Label for First Aid Antifungal Medicated

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - WHEN USING
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - DO NOT USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTHER
    13. PRINCIPAL DISPLAY PANEL

First Aid Antifungal Medicated Product Label

The following document was submitted to the FDA by the labeler of this product Anicare Pharmaceuticals Pvt. Ltd. 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 athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • proven effective in the prevention of 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 shoes and change 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 scalps or nails

Other Information



  • store between 20 to 25°C (68 to 77°F)
  • Lot No & Expiration Date: See box or see crimp

Inactive Ingredients



petrolatum, cetanol, liquid paraffin, methylparaben, polyoxyethylene,  propylene glycol, propylparaben, purified water, sorbitan monstearate, stearyl alchol.


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