VAGISTEN-V 7 DAY (MICONAZOLE NITRATE) CREAM [HEALTH LIFE]

VAGISTEN-V 7 DAY (MICONAZOLE NITRATE) CREAM [HEALTH LIFE]
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NDC 69517-612-01, 69517-612-05
Set ID 2a3827df-fbee-4d03-9152-3bea4fbb4010
Category HUMAN OTC DRUG LABEL
Packager HEALTH LIFE
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • ACTIVE INGREDIENTS

    MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)

  • PURPOSE

    VAGINAL ANTIFUNGAL

  • USES

    • TREATS VAGINAL YEAST INFECTIONS
    • RELIEVES EXTERNAL ITCHING AND URINATION DUE TO VAGINAL YEAST INFECTION

  • WARNINGS

    FOR VAGINAL USE ONLY.

    DO NOT USE IF YOU HAVE NEVER HAD A VAGINAL YEAST INFECTION DIAGNOSED BY A DOCTOR.

    ASK A DOCTOR BEFORE USE IF YOU HAVE

    • VAGINAL ITCHING AND DISCOMFORT FOR FIRST TIME
    • LOWER ABDOMINAL, BACK OR SHOULDER PAIN, FEVER, CHILLS, NASEA, VOMITING, OR FOUL-SMELLING VAGINAL DISCHARGE. YOU MAY HAVE A MORE SERIOUS CONDITION.
    • VAGINAL YEAST INFECTIONS OFTEN (SUCH AS ONCE A MONTH OR 3 IN 6 MONTHS). YOU COULD BE PREGNANT OR HAVE SERIOUS UNDERLYING MEDICAL CAUSE FOR YOUR SYMPTOMS, INCLUDING DIABETES OR A WEAKENED IMMUNE SYSTEM.
    • BEEN EXPOSED TO THE HUMAN IMMUNODEFICIENCY VIRUS (HIV) THAT CAUSES AIDS.

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE TAKEN A PRESCRIPTION BLOOD THINNING MEDICINE, SUCH AS WARFARIN, BECAUSE BLEEDING OR BRUISING MAY OCCUR.

    WHEN USING THIS PRODUCT

    • DO NOT USE TAMPONS, DOUCHES, SPERMACIDES OR OTHER VAGINAL PRODUCTS. CONDOMS AND DIAPHRAGMS MAY BE DAMAGED OR FAIL TO PREVENT PREGNANCY OR SEXUALLY TRANSMITTED DISEASES (STDS).
    • DO NOT HAVE VAGINAL INTERCOURSE
    • MILD INCREASE IN VAGINAL BURNING, ITCHING OR IRRITATION MAY OCCUR.

    STOP USE AND ASK A DOCTOR IF

    • SYMPTOMS DO NOT GET BETTER IN 3 DAYS
    • SYMPTOMS LAST MORE THAN 7 DAYS
    • YOU GET A RASH OR HIVESS, ABDOMINAL PAIN, FEVER, CHILLS, NAUSEA, VOMITING OR FOUL-SMELLING DISCHARGE

    IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • If swallowed get medical help or contact Poison Control Center right away.
  • DIRECTIONS

    • BEFORE USING THIS PRODUCT READ THE ENCLOSED CONSUMER INFORMATION LEAFLET FOR COMPLETE DIRECTIONS AND INFORMATION
    • ADULTS AND CHILDREN 12 YEARS OF AGE OR OVER:
    • APPLICATOR: INSERT 1 APPLICATOR INTO THE VAGINA AT BEDTIME FOR 7 NIGHTS IN A ROW. THROW APPLICATOR AWAY AFTER USE.
    • EXTERNAL CREAM: USE THE SAME TUBE OF CREAM IF YOU HAVE ITCHING AND IRRITATION ON THE SKIN OUTSIDE THE VAGINA. SQUEEZE A SMALL AMOUNT OF CREAM ONTO YOUR FINGERTIP. APPLY TO ITCHY, IRRITATED SKIN OUTSIDE THE VAGINA (VULVA). USE 2 TIMES DAILY FOR UP TO 7 DAYS AS NEEDED.
    • CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR.

  • INACTIVE INGREDIENTS

    BENZOIC ACID, BUTYLATED HYDROXYANISOLE, GLYCERINE STEARATE, MINERAL OIL, PEGLICOL 5 OLEATE, PEGOXOL 7 STEARATE, PURIFIED WATER

  • OTHER INFORMATION

    • DO NOT USE IF SEAL TUBE OPENING HAS BEEN PUNCTURED
    • DO NOT PURCHASE IF CARTON OPEN
    • STORE AT 20° - 25°C (68°F - 77°F)
  • PRINCIPAL DISPLAY PANEL

    0-UC_VAGISTEN-V  CREMA 2pct_front

    0-UC_VAGISTEN-V  CREMA 2pct_back

  • INGREDIENTS AND APPEARANCE
    VAGISTEN-V  7 DAY
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-612
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    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:69517-612-051 in 1 BOX09/05/2018
    1NDC:69517-612-0114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/05/2018
    Labeler - HEALTH LIFE (079656178)

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