topcare miconazole 3 description, usages, side effects, indications, overdosage, supplying and lots more!

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topcare miconazole 3

Topco Associates LLC

Topco Miconazole 3 Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Miconazole nitrate 4% (200 mg in each applicator)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

topcare miconazole 3 Uses

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • 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

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 hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a 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 and over:
  • applicators: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
  • external cream: squeeze a small amount of cream onto your fingertip. 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 of age: ask a doctor

topcare miconazole 3 Other information

  • do not use if printed applicator wrapper is missing or damaged (each applicator is individually wrapped)
  • do not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

  • miconazole 4% (prefilled applicators): benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
  • miconazole 2% (external cream): benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions or comments?

1-888-423-0139

Principal Display Panel

3-Day Treatment

Miconazole 3

Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)

Vaginal Antifungal

Combination Pack

(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)

Cures Most Vaginal Yeast Infections

Relieves Associated External Itching and Irritation

3 Prefilled Disposable Applicators Plus External Vulvar Cream

Compare to Monistat® 3 active ingredients

topcare miconazole 3
Miconazole 3 Carton

topcare miconazole 3

Miconazole nitrate KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-982
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-982-00 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076357 2004-11-17


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Be sure to consult your doctor before taking any medication!
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