Product Name:



Tioconazol 6.5 %

Pharmaceutical Form:

Cream & Ointment


Oint. 4.6 g

Pharmacologic Category:

Dermal and Genital


UNITOL (tioconazole 6.5%) is a single dose treatment for recurrent vaginal yeast infections.


UNITOL is indicated for the treatment of recurrent vaginal yeast infections previously diagnosed by a physician.

If this is the first time vaginal itch and discomfort have been present, a doctor should be consulted. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this ointment as directed.

Studies have shown that women taking oral contraceptives have cure rates similar to those not taking such agents when treated with UNITOL.
Safety and effectiveness in pregnant and diabetic patients have not been established.


UNITOL is contraindicated in individuals who have been shown to be sensitive to imidazole antifungal agents or to other components of the ointment.

Side Effects:

The incidence of adverse reactions to UNITOL is based on clinical trials involving 1000 patients.

Burning and itching were the most frequent side effects occurring in approximately 6 % and 5 % of patients, respectively.

In most instances these did not interfere with the course of therapy.

There were occasional reports (less than 1 %) of other side effects including irritation, discharge, vulvar swelling, vaginal pain, dysuria, (pain on urination), nocturia, (nighttime urination),dyspareunia, (painful intercourse), dryness of vaginal secretions, desquamation, (peeling skin), and burning sensation.


There are no adequate and well-controlled studies in pregnant women.
UNITOL (tioconazole 6.5 %) should be used during pregnancy only if the physician believes the potential benefit justifies the potential risk to the fetus.

<B>Nursing Mothers:</B>
It is not known whether this durg is excreted in human milk. Because many durgs are excreted in human milk, nursing should be temporarily discontinued while UNITOL is administered.

<B>Pediatric Use:</B>
Safety and effectiveness in children have not been established.

- Do not use if you have abdominal pain, fever, chills, nausea, vomiting, diarrhea, or foul-smelling discharge. Contact your doctor immediately.
- If your symptoms do not improve in 3 days or if you still have symptoms after 7 days, consult your doctor. Your doctor may recommend other treatment, or you may have a condition other than a yeast infection.
- If your symptoms return within 2 months, consult your doctor immediately.

Recurring yeast infections may be a sign of pregnancy or a serious condition.
- Do not use if you are pregnant or think you may be pregnant, have diabetes. Consult your doctor.
- Do not use tampons while using this medicine. Use sanitary napkins instead.
- Do no rely on condoms or diaphragms to prevent sexually transmitted diseases or pregnancy while using UNITOL.

This product may damage condoms and diaphragms and may cause them to fail. You should wait 3 days after treatment to resume using condoms or your diaphragm.
- Do not use in girls under 12 years of age.
- Keep this and all drugs out of the reach of children.
- UNIOL is for vaginal use only. Do not use in eyes or take by mouth.

In case of accidental ingestion, seek professional assistance.


Insert one applicatorful intravaginally. Remove prefilled applicator and plunger from foil packet. Hold capped end of applicator and push tip of plunger into base of applicator.

Remove the cap with a pull twist action. Insert applicatorful intravaginally while lying on your back with knees bent. Push plunger into applicator until it will go no further.

Withdraw applicator and plunger and dispose of in wastebasket. Administration of UNITOL just prior to bedtime is recommended.

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