Secura Antifungal Cream
FDA Label NDC 69740-329

10 label sections · Submitted to the FDA by Smith & Nephew Medical Ltd · 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 69740-329). 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, updated in line with latest otc monograph, keep out of reach of children, directions, question or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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
    • For jock itch: If irritation occurs or it there is no improvement within 2 weeks, discontinue use and consult a doctor
    • For the treatment of athlete's foot and ringworm: If irritaion occurs or it there is no improvement within 4 weeks, discontinue use and consult a doctor
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Keep Out Of Reach Of Children

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

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • 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

Inactive Ingredients

Antifungal Greaseless
allantoin, cetearyl alcohol, ceteth-20, citric acid, diazolidinyl urea, dioctyl adipate, glyceryl stearate, methylparaben, octyl palmitate, octyl stearate, PEG-40 castor oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium citrate, tocopheryl acetate, water

Antifungal Extra Thick
benzethonium chloride, butylparaben, cellulose gum, diazolidinyl urea, methylparaben, methyl glucose dioleate, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum, zinc oxide

Package Label.Principal Display Panel

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA ANTIFUNGAL EXTRA THICK - TUBE(92g)

Item #59432900

NDC 69740-329-00

Antifungal Extra Thick

2% Miconazole Nitrate
Cures most jock itch (tinea cruris), ringworm (tinea corporis), and athlete's foot (tinea pedis)
Relieves burning, itching, scaling, cracking, chafing and redness associated with these conditions
Pediatric tested
CHG Compatible
Can be used on denuded skin

Smith & Nephew

Secura

Antifungal Extra Thick

Made in India for:

Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN England

Trademark of Smith & Nephew

Certain marks Reg'd U.S. Pat & Tm. Off.

69740-329 (69740 329 00)

69740-329 (69740 329 00)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA ANTIFUNGAL GREASELESS - TUBE(57g)

Item #59432800

NDC 69740-328-00

Antifungal Greaseless

2% Miconazole Nitrate
Cures most jock itch (tinea cruris), ringworm (tinea corporis), and athlete's foot (tinea pedis)
Relieves burning, itching, scaling, cracking, chafing and redness associated with these conditions
Pediatric tested
CHG compatible

Smith & Nephew

Secura

Antifungal Greaseless

Made in India for:


Smith & Nephew Medical Ltd, 101 Hessle Road, Hull HU3 2BN, England

Trademark of Smith & Nephew

Certain Marks Reg'd U.S. Pat & Tm. Off.

69740-328 (69740 328 00)

69740-328 (69740 328 00)

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