Label: MICONAZOLE NITRATE cream

  • NDC Code(s): 70677-1000-1
  • Packager: STRATEGIC SOURCING SERVICES LLC
  • 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 July 19, 2023

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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 use on children less than 2 years of age unless directed by a doctor

    When using this product avoid 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 FINALpart333C07/14/2023
    Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(70677-1000)
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