Miconazole Nitrate 2% Cream
FDA Label NDC 71399-0071

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Miconazole Nitrate 2% (NDC 71399-0071). 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, directions, warnings, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Miconazole Nitrate, USP 2%

Purpose

Anti-Fungal

Uses

  • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
  • for effective relief of itching, scaling, cracking, burning, and discomfort

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  
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks 
  • if condition lasts longer, contact a doctor + this product is not effective on the scalp or nails

Warnings

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

When using this product, avoid contact with the eyes.

Stop use and ask a doctor if

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

Other Information

  • do not use if foil seal on tube opening is broken or missing 
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • store at room temperature 20°-25°C (68°-77°F)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient

Inactive ingredients cetostearyl alcohol, chlorocresol, disodium EDTA, disodium hydrogen phosphate, dihydrate, light liquid paraffin,
macrogol cetostearyl ether, propylene glycol, purified water, sodium dihydrogen phosphate dihydrate, white soft paraffin

Package Label.Principal Display Panel

14 (14g Lbl)

14 (14g Lbl)

28 (28g Lbl)

28 (28g Lbl)

42 (45g Lbl)

42 (45g Lbl)

* Please review the disclaimer below.