FDA Label for Defense Antifungal Medicated Bar

View Indications, Usage & Precautions

Defense Antifungal Medicated Bar Product Label

The following document was submitted to the FDA by the labeler of this product Defense Soap 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.

Active Ingredient



Tolnaftate 1%


Purpose



Antifungal


Uses



  • Proven clinically effective in the treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris).
  • For effective relief of itching, burning and cracking skin.

Warnings



For external use only


When Using This Product



When using this product avoid contact with the eye


Stop Use And Ask A Doctor If



Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.


Do Not Use



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


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 well and let product sit 1-2 minutes before rinsing.
  • Make sure to dry affected area thoroughly.
  • 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 and change shoes and socks at least once daily.
  • Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

Inactive Ingredients



Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid, Charcoal Powder


Principal Display Panel



Tolnaftate 1%

Antifungal
Medicated Bar Soap
Cures and Prevents Most Fungal Skin Infections, Including Athlete’s Foot, Ringworm and Jock Itch.


DEFENSE SOAP Products are tested everyday in the toughest, dirtiest places in the world—the world of combat sports. Wrestlers, MMA fighters, and Jiu-Jitsu athletes are prone to getting fungal skin infections. It’s the nature of contact sports. These elite athletes use DEFENSE SOAP as part of their daily training regimen because they know it works. We use only the highest quality ingredients at full strength concentrations.

DEFENSE SOAP LLC, 13000 ATHENS AVE STE C313 LAKEWOOD, OH 44107 866-544-1689


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