Antifungal Ringworm Treatment Spray
FDA Label NDC 83004-030

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 Antifungal Ringworm Treatment (NDC 83004-030). 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 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 2%

Purpose

Anti-fungal

Uses

  • effectively treats most of  cases of ringworm (tinea corporis) and related fungal infections.
  • helps relieve itching, redness, flaking, and irritation commonly associated with ringworm and similar skin conditions.

Directions

Adults and children 12 years and over

  • Wash the affected skin with soap and water and dry completely before applying.
  • for ringworm: apply a thin layer to the affected skin once daily (morning  or night) for 1 week, or as directed by a doctor
  • severe or persistent cases: use twice daily (morning  and evening) for up to 2 weeks, or as directed by a doctor
  • allow the product to fully dry on the skin before dressing
  • wash hands after each use children under 12 years: ask a doctor.

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

      . Do not get into the 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.

Other Information

  • do not use if seal on box is brken or is not visible
  • 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, Mel (Manuka Honey) Extract.

Product Label

Image Description (Image 30)

Image Description (Image 30)

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