Defense Antifungal Medicated Bar Soap
FDA Label NDC 70856-3581

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Defense Soap Llc for the product Defense Antifungal Medicated Bar (NDC 70856-3581). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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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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