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  5. Label Information: Antifungal

FDA Label for Antifungal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. QUESTIONS
    11. STORAGE
    12. PACKAGE LABEL

Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Pss World Medical, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.