Label: MICONAZOLE NITRATE cream

  • NDC Code(s): 70677-1000-1
  • Packager: STRATEGIC SOURCING SERVICES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 15, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Miconazole nitrate USP 2%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
    • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions
  • Warnings

    For external use only

    Do not useon children less than 2 years of age unless directed by a doctor

    When using this productavoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • condition persists
    • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • 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, and 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
    • not effective on the scalp or nails
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
    • to open: unscrew cap, use the pointed end on cap to puncture seal
    • store at 20° to 25°C (68° to 77°F)
    • see carton flap or tube crimp for lot number and expiration date
  • Inactive ingredients

    benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water

  • Questions?

    call 833-358-6431

  • SPL UNCLASSIFIED SECTION

    Distributed by:McKesson Corp.,
    via Strategic Sourcing Services LLC.
    Memphis, TN 38141

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    Foster & Thrive™

    Antifungal Cream

    Miconazole Nitrate Cream USP, 2%
    ANTIFUNGAL

    NET WT 1 OZ (30 g)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-7 LINOLEOYL GLYCERIDES (UNII: 993L8OB0ER)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1000-11 in 1 CARTON07/14/2023
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00507/14/2023
    Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharma Canada Inc.243339023manufacture(70677-1000)
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