Cidacin Antifungal Treatment Solution
FDA Label NDC 51151-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pedicis Research Llc for the product Cidacin Antifungal Treatment (NDC 51151-000). 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, active ingredient, purpose, uses, warnings, do not use, 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

Drug Facts


Active Ingredient

Tolnaftate  1%

Purpose

Antifungal

Uses

For the cure of most ringworm (tinea orporis) and athletes foot (tinea pedis) fungal infections.  For the relief of itching; burning; scaling; cracking; redness; soreness; irritation; discomfort that may accompany fungal infections.

Warnings

For external use only.

Do Not Use

on children unless directed by a doctor.

When Using This Product

avoid eye contact.  If eye contact occurs, rinse thoroughly with water for 10-15 minutes.

Stop Use And Ask A Doctor If

  •  if irritation occurs
  • no improvement is seen 4 weeks.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Consult A Physician

before beginning treatment if pregnant/breast feeding.

Directions

  • Clean affected area with soap and water, rinse and dry thoroughly.
  • Apply to affected areas twice daily (morning and night) or as directed by physician.
  • Supervise children in the use of the product. 
  • For athlete's foot: Pay special attention to spaces between the toes.
  • For athlete's foot and ringworm:  Use daily for 4 weeks.  If condition persists longer, consult physician.
  • Formula will dry completely in several minutes without residue.
  • Change socks regularly at least once a daily.
  • Wear well-fitted, ventilated shoes.

Inactive Ingredients

Dimethyl Sulfoxide (DMSO), Green Tea Extract, Ascorbic Acid (Vitamin C), Povidone Iodine, Vitamin E Acetate

Questions:

call 1-800-748-6539

Package Label.Principal Display Panel

PROFESSIONAL DISPENSED ONLY BY PHYSICIANS   CIDACIN Antifungal Treatment  PROFESSIONAL  Advanced Antifungal Solution  15mL / 0.5 oz  Distributed by  Pedicis Research LLC Radnor, PA 19087     Patent Pending

Cidacin Antifungal Treatment 15Ml (51151-000-01)


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