FDA Label for Monistat 3

Purpose

Miconazole nitrate (200 mg in each suppository)……………….…………...Vaginal antifungal

Miconazole nitrate 2% (external cream)……………………………………….Vaginal antifungal

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 the prescription blood thinning medicine 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
  
• if you do not get complete relief ask a doctor before using another product.

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                                      

Drug Facts (continued)

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:
  ○ suppositories: insert 1 suppository into the vagina at bedtime for three 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.

Other Information

• do not use if printed suppository blisters are torn, open or incompletely sealed
  
• 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

suppository: hydrogenated vegetable oil base

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.

Questions? If you have any questions or comments, please call 1-877-666-4782 

Principal Display Panel

MONISTAT® 3

COMBINATION PACK

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

VAGINAL ANTIFUNGAL

3 Vaginal Suppositories With             Net Wt. 3 Suppositories +

3 Applicators plus External Cream             0.32oz (9g) tube

PRINCIPAL DISPLAY PANELMONISTAT® 3 COMBINATION PACKMiconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL3 Vaginal Suppositories With Net Wt. 3 Suppositories +3 Applicators plus External Cream 0.32oz (9g) tube - monistat 3 cure itch relief suppository cream 01