Jock Itch Miconazole Nitrate Cream
FDA Label NDC 83004-031

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Jock Itch Miconazole Nitrate (NDC 83004-031). 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, warnings, directions, other information, inactive ingredients, 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

  • For the relief of symptoms associated with jock itch (tinea cruris).
  • For effective relief of itching, burning, scaling, discomfort, and chafing associated with jock itch.

Warnings

  • For external use only

    • Do not use

    • on nails or scalp
    • in or near the mouth or eyes
    • for vaginal yeast infections

      • When using this product. avoid contact eyes. If eye contact occurs, rinse thoroughly with water.

      Stop use and ask a doctor if too much irritation occurs or gets worse.

      Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 

Directions

Adults and children 12 years and over:
• Wash affected area and dry thoroughly.
• Apply a thin layer over affected area twice daily (morning and night).
• Supervise children in use of this product.
• Use daily for 2 weeks.
• If condition persists longer, ask a doctor.
• This product is not effective on the scalp or nails.
• Wash hands after each use.
• Children under 12 years: ask a doctor.

Other Information

Do not use if seal on tube is broken or missing. Store at controlled room temperature 20–25°C (68–77°F).

Inactive Ingredients

Organic Tea Tree Oil, Benzoic Acid, Cetyl Alcohol, Isopropyl Myristate, Polysorbate 60, Oxygenated Olive Oil, Potassium Hydroxide, Propylene Glycol, Purified Water, Stearyl Alcohol.

Product Label

Image Description (Image 31)

Image Description (Image 31)

* Please review the disclaimer below.