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FDA LABEL
GENERIC: Tioconazole MFR: Insight Pharmaceuticals LLC
Monistat Simple Therapy 6.5 % Vaginal Ointment
Table of Contents
Drug Facts
Tioconazole 300 mg (6.5%)
Vaginal antifungal
INDICATIONS AND USAGE
- treats vaginal yeast infections
WARNINGS
For vaginal use only
if you have never had a vaginal yeast infection diagnosed by a doctor.
-
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
- 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
-
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 .
ask a health professional before use
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
DOSAGE AND ADMINISTRATION
- before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
- adults and children 12 years of age and over:
○ open the foil packet just before use and remove purple cap
○ insert entire content of applicator into the vagina at bedtime. Throw applicator away after use.
- children under 12 years of age: ask a doctor.
- this product is a 1-dose treatment. Most women do not get complete relief of their symptoms in just one day. Most women get some improvement in one day and complete relief of symptoms within 7 days.
- if you have questions about vaginal yeast infections, consult your doctor
- store at 20°-25°C (68°-77°F)
- see end flap of carton for lot number and expiration date
butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum
1-877-666-4782
ASK A DOCTOR
MONISTAT®
Tioconazole Ointment 6.5%
VAGINAL ANTIFUNGAL
Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR