MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]

MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]
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NDC 42254-319-30
Set ID 74a80da6-0279-4946-b7ee-d3e43330ba2c
Category HUMAN OTC DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • relieves itching, scaling, cracking, burning and discomfort associated with those conditions
  • Warnings

  • For external use only

  • Do not use

    on children under 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 or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
    • irritation occurs or if there is no improvement within 2 weeks (for jock itch)
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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:

    • use daily for 4 weeks. If condition persists longer, consult a doctor.
    • pay special attention to the spaces between the toes
    • wear well-fitting, ventilated shoes
    • change shoes and socks at least once daily

    For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

    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.

  • Other information

    • store at 15° - 30°C (59° - 86°F)
    • lot number and expiration date: see crimp of tube or see box
    • to open: unscrew cap, use pointed end on cap to puncture seal

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

  • Inactive ingredients

    benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 10/09 R2
    8280719 7805

    Repackaged by
    Rebel Distributors Corp.
    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL

    Miconazole Nitrate 2%
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-319(NDC:0603-7805)
    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 HYDROXYANISOLE (UNII: REK4960K2U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-5 OLEATE (UNII: 0240V77G50)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-319-301 in 1 CARTON
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/01/2003
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    NameAddressID/FEIBusiness Operations
    PSS World Medical, Inc.791528623REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    STAT RX USA LLC786036330REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785RELABEL(42254-319) , REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    SCRIPT PAK964420108RELABEL(42254-319) , REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keltman Pharmaceuticals, Inc.362861077REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distirbutors Corp.118802834RELABEL(42254-319) , REPACK(42254-319)

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