Drug Reference
Tioconazole
Imidazole derivatives
OTC
Fact box
- Therapeutic class
- Imidazole derivatives
- Action class
- Azole Antifungal
- Chemical class
- Azoles
- Habit forming
- No
- Availability
- Over-the-counter (OTC)
Brand names
Monistat Simple TherapyVagistat-1
Available as
0.065 MG/MG
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
Use • treats vaginal yeast infections
How to use / dosing
Directions • before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information • adults and children 12 years of age and over: • open the printed packet just before use and remove purple cap • insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. • children under 12 years of age: ask a doctor
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyConsult your doctor
…You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.…
BreastfeedingConsult your doctor
…nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use.…
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
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 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 disease (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 after 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 (1-800-222-1222).
Current FDA labels (DailyMed)
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.