Antifungal
FDA Label NDC 68345-817

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pss World Medical, Inc. for the product Antifungal (NDC 68345-817). 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, do not use, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Treats jock itch, ringworm, and athlete's foot.

​INDICATIONS:​ Proven clinically effective in the treatment athlete's foot, jock itch and ringworm. Treats superficial skin infections caused by yeast. For effective relief of redness, irritation, itching, and burning.

Warnings

​For external use only.​

​PRECAUTIONS:​ For external use only. Not intended for ingestion. Avoid contact with eyes.

Do Not Use

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

Stop Use And Ask A Doctor If

Stop use and ask a doctor if​

  • irritation develops
  • there is no improvement within 4 weeks for athlete's foot or ringworm
  • or within 2 weeks for jock itch

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

​Directions​

  • clean the affected area and dry thoroughly
  • apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
  • supervise children in the use of this product

    • ​Athlete's Foot​

    • pay special attention to the spaces between toes
    • wear well-fitting, ventilated shoes and change shoes and socks at least once daily

      • ​Athlete's Foot and Ringworm​

      • use daily for 4 weeks

        • ​Jock Itch​

        • use daily for 2 weeks

          • This product is not effective on scalp or nails.

Inactive Ingredients

BHT, Cetostearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Magnesium Aluminum Silicate, Petrolatum, Propylparaben, Polyoxyl 40 Stearate, Purified Water.

Questions

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Comments or Questions? 800-777-4908

Made in China

Storage

Store at room temperature 15-30C (59-86F).

Package Label

NDC 68345-817-25

6391 Each

6391 Box

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