Tritolnacide S Solution
FDA Label NDC 73352-560

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifluent Pharma Llc for the product Tritolnacide S (NDC 73352-560). 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 other, active ingredient, purpose, uses, warnings, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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DRUG FACTS

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • Treats most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis)
  • Relieves discomfort, irritation, cracking, scaly skin between the toes and itching, burning feet.

Warnings

For external use only.

Ask A Doctor Or Pharmacist Before Use If You Are

  • Using any other medicines or cleansers on your skin

When Using This Product

  • Avoid contact with eyes: rinse immediately with cool tap water if contact occurs.
  • Do not use for vaginal yeast

Stop Use And Ask A Doctor If

  • Irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Do not use on children under 2 years of age unless directed by a doctor.

Directions

  • Wash the affected area with soap and water and dry thoroughly
  • Apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor
  • For Athlete's Foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • Supervise children in the use of this product
  • For Athlete's Foot and Ringworm, use daily for 4 weeks; for Jock Itch, use daily for 2 weeks. If condition persists longer, consult a doctor
  • This product is not effective on the scalp or nails
  • Wash hands after each use

Inactive Ingredients

Butylparaben, butylated hydroxyanisole, butylated hydroxytoluene, Carthamus tinctorius (safflower) seed oil, ethylparaben, isobutylparaben, methylparaben, Origanum vulgare (oregano) leaf oil, phenoxyethanol, propylparaben, Simmondsia chinensis (jojoba) seed oil, tocopherol, white mineral oil.

Questions Or Comments?

CALL (210) 944-6920

Principal Display Panel - 15 Ml Bottle Label

PRODUCT SHOULD BE ADMINISTERED UNDER
THE SUPERVISION OF A
LICENSED MEDICAL PRACTITIONER

TRIFLUENT
PHARMA®

TriTolnacide™ S
ANTIFUNGAL SOLUTION

TOLNAFTATE

NDC 73352-560-01
0.5FL OZ (15 mL)

Principal Display Panel (15 mL Bottle Label)

Principal Display Panel (15 mL Bottle Label)

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