Active Ingredients
Miconazole nitrate 2%
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.
Miconazole nitrate 2%
Antifungal
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
Addition of 'Unless directed by doctor' to 'Do not use on children under 2 years old'.
Separation and expansion of 'For jock itch' and 'For athlete's foot and ringworm' warnings
For athlete's foot:
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.
1 800 876-1261
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 - 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.
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.
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