FDA Label for Miconazole 1 Walgreens

View Indications, Usage & Precautions

Miconazole 1 Walgreens Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Miconazole nitrate 1200 mg (in 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 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 the applicator, place the vaginal insert into the vagina. 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 (vulva). 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 pouch is 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)
  • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.

Inactive Ingredients



vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum

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 - Kit Carton



Miconazole
Miconazole Nitrate Vaginal Insert (1200 mg)

Miconazole Nitrate Cream (2%)


VAGINAL ANTIFUNGAL | 1-DAY TREATMENT

Net Wt. 0.32oz (9g) tube & 1 OVULE Insert


* Please review the disclaimer below.