Miconazole
FDA Label NDC 50382-050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galentic Pharma (india) Priva Te Limited for the product Miconazole (NDC 50382-050). 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, uses - antifungal, warnings, directions, other information., inactive ingredients, keep out of reach of children, principal display panel, 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%

Uses - Antifungal

  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
  • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.

Warnings

Do not use:

  • Do not use on children under 2 years of age unless directed by a doctor.
  • Avoid contact with eyes.
  • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions



  • Supervise children in the use of this product.
  • If conditions persist longer, consult a doctor.
  • This product is not effective on scalp or nails.
    • Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
    • Foe athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks.
    • For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Other Information.

Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

Keep Out Of Reach Of Children

  • KEEP OUT OF REACH OF CHILDREN
  • If swallowed get medical help or contact a Poison Control Center.

Principal Display Panel

Principal Display Panel

Miconazole Nitrate Cream USP 2%


Gal Miconazole.jpg

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