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

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Miconazole 7

Major

Miconazole 7 Cream - Major Pharmaceuticals




FULL PRESCRIBING INFORMATION

Drug Facts

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (external cream)

Vaginal antifungal

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

For 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
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
  • lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

  • do not use tampons, douches, spermicides or other vaginal products
  • do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse (sex)
  • mild increase in vaginal burning or irritation may occur
  • symptoms do not get better after 3 days
  • symptoms last more than 7 days
  • you get a rash, 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 brochure for complete instructions
  • adults and children 12 years of age and over:
     applicator: insert one applicatorful into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
     external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina.
    Use 2 times daily for up to 7 days as needed.
  • children under 12 years: ask a doctor
  • to open tube use cap to puncture seal
  • do not purchase if carton is opened
  • do not use if seal over tube opening has been punctured or is not visible
  • store at room temperature 15º - 30ºC (59º - 86ºF), avoid heat (over 30ºC or 86ºF).

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

Call 1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday – Friday.

MAJOR®
NDC 0904-7734-45

MICONAZOLE 7
MICONAZOLE NITRATE VAGINAL CREAM (2%)
VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING & IRRITATION
(MICONAZOLE NITRATE 100 mg PER APPLICATOR)

COMPARE TO the active ingredient of Monistat®7*

7-DAY VAGINAL CREAM with Reusable Applicator

NET WT 1.59 OZ (45 g) TUBE

Miconazole 7

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (external cream)

Vaginal antifungal

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

For 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
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
  • lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

  • do not use tampons, douches, spermicides or other vaginal products
  • do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse (sex)
  • mild increase in vaginal burning or irritation may occur
  • symptoms do not get better after 3 days
  • symptoms last more than 7 days
  • you get a rash, 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 brochure for complete instructions
  • adults and children 12 years of age and over:
     Applicator: insert one applicatorful into the vagina at bedtime for 7 days in a row. Throw applicator away after use.
     external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina.
    Use 2 times daily for up to 7 days as needed.
  • children under 12 years: ask a doctor
  • to open tube use cap to puncture seal
  • do not purchase if carton is opened
  • do not use if seal over tube opening has been punctured or is not visible
  • store at room temperature 15º - 30ºC (59º - 86ºF), avoid heat (over 30ºC or 86ºF).

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

Call 1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday – Friday.

MAJOR®
NDC 0904-7734-57

MICONAZOLE 7
MICONAZOLE NITRATE VAGINAL CREAM (2%)
VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING & IRRITATION
(MICONAZOLE NITRATE 100 mg PER APPLICATOR)

COMPARE TO the active ingredient of Monistat®7*

7- AY VAGINAL CREAM with Disposable Applicators

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:0904-7734
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
2 45 in 1 TUBE, WITH APPLICATOR
3 NDC:0904-7734-45 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074164 2009-04-21


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