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FDA LABEL GENERIC: Tioconazole MFR: Insight Pharmaceuticals LLC

Monistat Simple Therapy 6.5 % Vaginal Ointment

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