Miconazole Nitrate
FDA Label NDC 54868-2471

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Miconazole Nitrate (NDC 54868-2471). 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, when using this product, 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 most athlete’s foot, jock itch and ringworm
  • relieves itching, scaling, burning, irritation and discomfort

Warnings

For external use only

When Using This Product

  • do not get into the eyes

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch)

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

Keep Out Of Reach Of Children

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

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product
  • this product does not work on the scalp or nails

    • 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 every day

      For athlete’s foot and ringworm

    • use every day for 4 weeks

      For jock itch

    • use every day for 2 weeks. If condition lasts longer, contact a doctor.

Other Information

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

IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.

TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.

Inactive Ingredients

Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Package Label.Principal Display Panel

NDC 54868-2471-0

Image Of Package Label (2471)

Image Of Package Label (2471)


Compare to the active ingredient in Micatin® Antifungal Cream*

Actavis

Antifungal Cream

Miconazole Nitrate 2%

Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm

Net wt. 14 g  tube cream

07350200D1 VC106266






Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

* Please review the disclaimer below.