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 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