Miconazole 7 description, usages, side effects, indications, overdosage, supplying and lots more!

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Miconazole 7

Cardinal Health (Leader)

Miconazole 7-Miconazole Nitrate Vaginal Cream 2




FULL PRESCRIBING INFORMATION

Drug Facts

Miconazole nitrate, USP 2% (100 mg in each applicator)

Vaginal antifungal

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

For vaginal use only

If you have never had a vaginal yeast infection diagnosed by a doctor

  • vaginal itching and discomfort for the first time
  • lower abdominal, back, or shoulder pain, fever, chills, nausea, 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 a 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

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

  • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
  • symptoms do not get better in 3 days
  • symptoms last more than 7 days
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

Ask a health professional before use.

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

  • before using this product read the enclosed consumer information leaflet for complete directions and information
  • adults and children 12 years of age and over:
    • applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
    • 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
  • to open tube use cap to puncture seal
  • do not use if seal over tube opening has been punctured or is not visible
  • do not purchase if carton is open
  • store at room temperature 15°- 30°C (59° - 86°F), avoid heat (over 30°C or 86°F.)

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

 1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

NDC 49781-064-75
LEADER®
Compare to Monistat 7®
active ingredient*

Miconazole 7
Miconazole Nitrate Vaginal Cream, USP 2%

Vaginal Antifungal
(Miconazole Nitrate 100 mg per applicator)

Cures most vaginal yeast infections
Relieves associated external itching and irritation

7 DAY VAGINAL CREAM (1 TUBE)
WITH 1 REUSABLE APPLICATOR

NET WT. 1.59 OZ (45 g) Tube

Miconazole 7

Miconazole 7

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49781-064
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 2 g

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
Mineral Oil
water
PEGOXOL 7 STEARATE

Product Characteristics

Color
WHITE (white to off white, viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 45 in 1 TUBE, WITH APPLICATOR
2 NDC:49781-064-75 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074164 2014-05-31


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Be sure to consult your doctor before taking any medication!
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