MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]

MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]
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NDC 21695-854-45
Set ID 6791d4f2-c485-4daf-82c7-0cafa9a7a17d
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% (100 mg in each applicator)

  • Purpose

    Vaginal antifungal

  • Keep Out of Reach of Children

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

  • Uses

    . treats repeat vaginal yeast infections
    . relieves external itching and irritation due to a repeat vaginal yeast infection

  • Warnings

    For vaginal use only
    Ask a doctor before use if you have
    . never had a vaginal yeast infection diagnosed by a doctor
    . 1 or more of the following:
    abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge
    . vaginal yeast infections often (such as once a month or 3 in 6 months)
    . been exposed to the human immunodeficiency virus (HIV) that causes AIDS
    Ask a doctor or pharmacist before use if you are taking the prescription
    blood thinning medication warfarin, because bleeding or bruising may occur.
    When using this product
    . do not use tampons, douches, spermicides, or other vaginal products
    . do not have vaginal intercourse
    . condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)
    Stop use and ask a doctor if
    . symptoms do not get better in 3 days
    . symptoms last more than 7 days
    . you get abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge, or rash
    If pregnant or breast-feeding, ask a health professional before use.

  • Other Information

    . do not purchase if printed "Safety Sealed" carton
    overwrap is broken or missing
    . do not use if seal over tube opening has been punctured or cannot be seen
    . store at room temperature 15°-30°C (59°-86°F), avoid heat over 30°C or 86°F.

  • Directions

    . before using this product read the enclosed consumer
    information leaflet for complete instructions
    . adults and children 12 years of age and over:
    . applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
    . external cream: squeeze a small amount of cream onto your fingertip.
    Gently apply the cream onto the itchy, irritated skin outside the
    vagina. Use daily for up to 7 days as needed
    . children under 12 years of age: ask a doctor

  • Inactive ingredients

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

  • Package/Label Principal Display Panel

    Miconazole Nitrate 2%

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-854(NDC:0713-0252)
    Route of AdministrationVAGINAL
    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:21695-854-4545 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2008
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK

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