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

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Miconazole 7

CDMA/Quality Choice

Miconazole 7 Cream - Quality Choice




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

F o r   vaginal use only

i f 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 each 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 15º - 30ºC (59º - 86ºF), avoid heat (over 30ºC or 86ºF).

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.

Compare to the active ingredient in Monistat®7 Vaginal Cream

Miconazole 7
Miconazole Nitrate Vaginal Cream, USP 2%

Vaginal Antifungal
(Miconazole Nitrate 100 mg per applicator)

Cures most vaginal yeast infections
and Relieves Associated External Itching and Irritation

1.59 OZ NET WT. (45 g) Tube

7 Day Vaginal Cream (1 Tube) with 1 Reusable Applicator

Miconazole 7

Miconazole 7

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-198
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
PEG-5 OLEATE
PEGOXOL 7 STEARATE
water

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:63868-198-45 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074164 2010-07-01


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Be sure to consult your doctor before taking any medication!
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