Fungus Relief
FDA Label NDC 65734-348

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Swabplus Inc. for the product Fungus Relief (NDC 65734-348). 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 drug facts, purpose, uses, warings, keep out of the reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • Cures fungal infections of the toes and fingers, including skin around and under nails, where accessible with swab applicator. Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) and relieves symptoms of athlete's foot including itching, burning and scaly skin.
  • Help prevent most athlete's foot from recuring when uses daily.

Warings

For external use only.
When using this product avoid contact with eyes.
Stop use and ask a doctor if irritation occurs. there is no improvement within 4 weeks.
Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Keep Out Of The Reach Of Children

If swallowed get  medical help or contact a Poison Control Center right away.

Directions

  • Do not use if label seal is broken prior to purchase.
  • Keep swabs in original container when not in use.
  • wash affected area and dry thoroughly.
  • Hold the swab vertically with the color band tip upwards.
  • Bend the tip at the color band to one side until it snaps.
  • Apply a thin layer over affected area twice daily (morning and night)
  • Discard swab after use.
  • For athlete's foot, apply once or twice daily, pay special attention to spaces between toes, wear shoes with good ventilation and change shoes and socks at least once daily.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

Other Information


Avoid storing at excessive heat.

Inactive Ingredients

Aloe Barbadensis Leaf Extract. BHT. Butylene Glycol, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Propylene Glycol, Propylparaben. Tocopheryl Acetate

Package Label.Principal Display Panel

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Image Of Fungus Carton Label (Fungus300348)

Image Of Fungus Carton Label (Fungus300348)

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