MICONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.]

MICONAZOLE NITRATE CREAM [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-2471-0
Set ID 1ff4dcb5-d4ac-4e4b-a1ae-993f28939942
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Miconazole nitrate 2%

  • PURPOSE

    Antifungal

  • USES

    • treats most athlete’s foot, jock itch and ringworm
    • relieves itching, scaling, burning, irritation and discomfort
  • WARNINGS

    For external use only

  • WHEN USING THIS PRODUCT

    • do not get into the eyes
  • STOP USE AND ASK A DOCTOR IF

    • irritation occurs
    • 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, unless directed by a doctor.

  • 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
    • this product does not work on the scalp or nails

    For athlete’s foot

    • pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once every day

      For athlete’s foot and ringworm

    • use every day for 4 weeks

      For jock itch

    • use every day for 2 weeks. If condition lasts longer, contact a doctor.
  • OTHER INFORMATION

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

    IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.

    TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.

  • INACTIVE INGREDIENTS

    Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 54868-2471-0

    image of package label

    Compare to the active ingredient in Micatin® Antifungal Cream*

    Actavis

    Antifungal Cream

    Miconazole Nitrate 2%

    Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm

    Net wt. 14 g  tube cream

    07350200D1 VC106266






    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2471(NDC:0472-0735)
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2471-01 in 1 CARTON
    114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C03/20/2012
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-2471)

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