Secura Antifungal Cream
FDA Label NDC 69740-328

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smith & Nephew Medical Ltd for the product Secura Antifungal (NDC 69740-328). 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 ingredients, purpose, uses, warnings, directions, question or comments?, secura antifungal greaseless, secura antifungal extra thick, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Miconazole nitrate 2%

Purpose

Antifungal

Uses

Antifungal Extra Thick

Cures most jock itch (tinea cruris), ringworm (tinea corporis) and athlete's foot (tinea pedis)

Antifungal Greaseless

Cures most athlete's foot, jock itch and ringworm


Warnings

  • For external use only

    • Do not use on children under 2 years old unless directed by a doctor

    • Avoid contact with the eyes
    • Stop use and ask a doctor if irritation occurs or if there is no improvement

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night)
  • supervise children in the use of this product

    • For athlete's foot:

    • pay special attention to the spaces between the toes
    • wear well fitting, ventilated shoes
    • change shoes and socks at least once daily

      • For athlete's foot and ringworm use daily for 4 weeks.

      For jock itch use daily for 2 weeks.


      If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Question Or Comments?

1 800 876-1261

Secura Antifungal Greaseless

allantoin, cetearyl alcohol, polyethylene glycol 1000 cetyl ether, citric acid, diazolidinyl urea, dioctyl adipate, glyceryl stearate, methylparaben, octyl palmitate, octyl stearate, PEG-40 castor oil, petrolatum, o-phenylphenol, propylparaben, sodium cetearyl sulfate, sodium citrate, tocopheryl acetate, water

Secura Antifungal Extra Thick

benzethonium chloride, butylparaben, cellulose gum, cetearyl alcohol, diazolidinyl urea, karaya gum, methylparaben, methyl glucose dioleate, mineral oil, petrolatum, tocopheryl acetate, water, zinc oxide

Secura Antifungal Extra Thick/Secura Antifungal Greaseless

Store at controlled room temperature 59oF-86oF (15oC-30oC)

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