Label: ANTIFUNGAL BODY- miconazole nitrate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 19, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient

    Miconazole Nitrate 2%

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  • PURPOSE

    Purpose

    Antifungal

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  • INDICATIONS & USAGE

    Uses

    • for treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    • relieves itching,scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
    • for treatment ofsuperficial skin infections caused by yeast (Candida albicans)
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  • WARNINGS

    Warnings

    • For External use only.

    ​When using this product

    • Do not get into eyes

    Stop use and ask a doctor if

    • irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch.

    Do not use on

    • children under 2 years of age unless directed by a doctor
    • diaper rash

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

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  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the affected area and dry thoroughly
    • Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
    • Supervise children in the use of this product

    Athlete’s foot

    • Pay special attention to the spaces between toes
    • Wear well-fitting, ventilated shoes and change shoes and socksat least once daily

    Athlete’s foot and ringworm

    • Use daily for 4 weeks

    Jock itch

    • Use daily for 2 weeks. If condition persists longer, consult a doctor.

    This product is not effective on scalp or nails.

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  • INACTIVE INGREDIENT

    Inactive ingredients
    Isopropyl Palmitate, Glyceryl Stearate, PEG 100 Stearate, Cyclopentasiloxane, Cetearyl Alcohol, Propylene Glycol, Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf Juice, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopherol Acetate (Vitamin E), Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Triethanolamine, DMDM Hydantoin, Iodopropynyl Butylcarbamate

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  • PRINCIPAL DISPLAY PANEL

    McKesson Thera Antifungal Body Cream

    Helps treat the most common fungal infections including athlete's foot, jock itch and ringworm.

    Single Patient Use

    Therapy [for the skin]

    Net Contents 4 fl oz (118ml)

    MFR# 53-AF4

    53-AFC4 each

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  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL BODY 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-0206
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    ALOE (UNII: V5VD430YW9)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LYSINE (UNII: K3Z4F929H6)  
    ARGININE (UNII: 94ZLA3W45F)  
    THREONINE (UNII: 2ZD004190S)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    GLYCINE (UNII: TE7660XO1C)  
    .BETA.-ALANINE (UNII: 11P2JDE17B)  
    VALINE (UNII: HG18B9YRS7)  
    METHIONINE (UNII: AE28F7PNPL)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    CYSTEINE (UNII: K848JZ4886)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    LEUCINE (UNII: GMW67QNF9C)  
    TYROSINE (UNII: 42HK56048U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    SERINE (UNII: 452VLY9402)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    HISTIDINE (UNII: 4QD397987E)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-0206-4 118 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 06/01/2017
    Labeler - McKesson (023904428)
    Establishment
    Name Address ID/FEI Business Operations
    Central Solutions 007118524 manufacture(68599-0206)
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