Sunmark miconazole 3 kit

Active ingredient

Miconazole nitrate (200 mg in each suppository)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

Uses

  1. treats vaginal yeast infections
  2. 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

  1. vaginal itching and discomfort for the first time
  2. lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
  3. 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.
  4. 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

  1. 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).
  2. do not have vaginal intercourse
  3. mild increase in vaginal burning, itching or irritation may occur

Stop use and ask a doctor if

  1. symptoms do not get better in 3 days
  2. symptoms last more than 7 days
  3. 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

  1. before using this product read the enclosed consumer information leaflet for complete instructions and information
  2. adults and children 12 years of age and over:
  3. suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Wash applicator after use.
  4. 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.
  5. children under 12 years of age: ask a doctor

Other information

  1. do not use if printed suppository wrapper is missing or damaged (each suppository is individually wrapped)
  2. do not use if seal over tube opening has been punctured or cannot be seen
  3. do not purchase if carton is open
  4. store at 20-25C (68-77F)

Inactive ingredients

suppository: hydrogenated vegetable oil

external cream: benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Sunmark miconazole 3 kit- Miconazole nitrate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49348-354
Route of Administration Vaginal

Product Characteristics

Color WHITE (white to off white)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075329 USA

Labeler - Strategic Sourcing Services LLC( 116956644)

Principal display panel

Compare to Monistat® 3 Combination Pack Active Ingredients

3 Day Treatment with Reusable Applicator

Miconazole 3

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Cream (2%)

Vaginal Antifungal

Combination Pack

Cures most vaginal yeast infections and relieves associated external itching & irritation

(Miconazole Nitrate 200 mg per Suppository Plus 2% External Vulvar Cream)

3 Vaginal Suppositories with Reusable Applicator plus External Vulvar Cream