FDA Label for Antifungal Ringworm Treatment

View Indications, Usage & Precautions

Antifungal Ringworm Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Rida Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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