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Secura Antifungal (Smith & Nephew, Inc.)

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CREAM 57 g in 1 TUBE (50484-328-00) Label Information

Complete Secura Antifungal Information

  • DRUG FACTS


  • 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

    • Avoid contact with the eyes

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

    • Stop use and ask a doctor if irritation occurs or if there is no improvement

    • Keep reach out of children. In case of ingestion, 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)
    • 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

    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


  • OTHER INFORMATION

    SECURA ANTIFUNGAL EXTRA THICK

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


  • PRINCIPAL DISPLAY PANEL


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

    Item #59432800

    NDC 50484-328-00

    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
    • Pediatrician tested

    Smith & Nephew

    Securaâ—Š

    Antifungal Greaseless

    Made in India for:
    Smith & Nephew, Inc., St. Petersburg, FL 33716 

    Trademark of Smith & Nephew

    Reg. U.S. Pat & Tm. Off.

    Package Display - Antifungal Greaseless



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

    Item #59432900

    NDC 50484-329-00

    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
    • Can be used on denuded skin
    • Pediatrician tested

    Smith & Nephew

    Securaâ—Š

    Antifungal Extra Thick

    Made in India for:
    Smith & Nephew, Inc., St. Petersburg, FL 33716 

    www.smith-nephew.com

    Trademark of Smith & Nephew

    Reg. U.S. Pat & Tm. Off.


    Package Display - Antifungal Extra Thick (92g)


  • INGREDIENTS AND APPEARANCE
    SECURA ANTIFUNGAL  GREASELESS
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-328
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN (UNII: 344S277G0Z) 2 mg  in 1 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.1 mg  in 1 g
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 2 mg  in 1 g
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 40 mg  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 3 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 3 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 150 mg  in 1 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 1.5 mg  in 1 g
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) 7 mg  in 1 g
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 23.5 mg  in 1 g
    WATER (UNII: 059QF0KO0R) 594.4 mg  in 1 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 109 mg  in 1 g
    CETETH-20 (UNII: I835H2IHHX) 10 mg  in 1 g
    ETHYLHEXYL PALMITATE (UNII: 2865993309) 8 mg  in 1 g
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 14 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-328-00 57 g in 1.0 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 08/01/2003 06/30/2018
    SECURA ANTIFUNGAL  EXTRA THICK
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-329
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) 1.3 mg  in 1 g
    BUTYLPARABEN (UNII: 3QPI1U3FV8) 0.5 mg  in 1 g
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 2 mg  in 1 g
    KARAYA GUM (UNII: 73W9IQY50Q) 70 mg  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 3 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) 40 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 400 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) 300 mg  in 1 g
    WATER (UNII: 059QF0KO0R) 21.2 mg  in 1 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2 mg  in 1 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 60 mg  in 1 g
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 30 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-329-00 92 g in 1.0 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 08/01/2003 06/30/2018
    Labeler - Smith & Nephew, Inc. (827731451)
    Establishment
    Name Address ID/FEI Business Operations
    ENCUBE ETHICALS PVT LTD 915834105 manufacture(50484-328, 50484-329)