FDA Label for Miconazole 3 Walgreen Company

Active Ingredients

Miconazole nitrate (200 mg in each vaginal insert)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

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.

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 (1-800-222-1222) 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:
  • vaginal insert: with a disposable applicator, place the insert 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 sealed pouches containing vaginal inserts 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

vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

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

Questions?

call toll-free 1-855-590-5695

Principal Display Panel

- Kit Carton

Miconazole 3

Miconazole Nitrate Vaginal Inserts (200 mg)

Miconazole Nitrate Cream (2%) 

Vaginal Antifungal | 3-Day Treatment

Net Wt. 0.32 oz (9 g) Tube & 3 Ovule Inserts

PRINCIPAL DISPLAY PANEL- Kit CartonMiconazole 3Miconazole Nitrate Vaginal Inserts (200 mg) Miconazole Nitrate Cream (2%) Vaginal Antifungal | 3-Day TreatmentNet Wt. 0.32 oz (9 g) Tube & 3 Ovule Inserts - miconazole 3 combination pack 01