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  5. Label Information: Athletes Foot

FDA Label for Athletes Foot

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL - 30 G TUBE CARTON

Athletes Foot Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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.

Other



Drug Facts

Distributed by McKesson
One Post Street
San Francisco, CA 94104


Active Ingredient



Terbinafine hydrochloride 1%


Purpose



Antifungal


Uses



  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions

Warnings



For external use only


Do Not Use



  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

Otc - When Using



When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.


Stop Use And Ask A Doctor If



  • too much irritation occurs or gets worse.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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



  • adults and children 12 years and older
    • use the tip of the cap to break the seal and open the tube
    • wash the affected skin with soap and water and dry completely before applying
    • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
      • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
      • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
      • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
      • wash hands after each use
      • children under 12 years: ask a doctor
1 week between the toes
Figure - terbinafine 01

Figure - terbinafine 01


2 weeks on the bottom or sides of the foot

Other Information



  • do not use if seal on tube is broken or is not visible
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients



benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.


Principal Display Panel - 30 G Tube Carton



sunmark®

athlete's foot cream

terbinafine hydrochloride cream 1%

antifungal cream

FULL PRESCRIPTION STRENGTH

NET WT 1 oz (30 g)

Principal Display Panel - 30 g Tube Carton - terbinafine 03

Principal Display Panel - 30 g Tube Carton - terbinafine 03


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