Tioconazole Ointment 6.5%

Tioconazole Ointment 6.5% Recall

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Side Effects & Adverse Reactions

For vaginal use only

Do not use 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 human immunodeficiency virus (HIV) that causes AIDS

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

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
adults and children 12 years and over: 1.Open the foil packet just before use and remove purple cap. 2.Insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
children under 12 years of age: ask a doctor

Do not use if sealed foil packet torn, open, or incompletely sealed.

1-DOSE TREATMENT

TIOCONAZOLE OINTMENT 6.5%

VAGINAL ANTIFUNGAL

DIRECTIONS FOR USE

Tear open foil packet just before using. It is best to use at bedtime.
Remove applicator and plunger from packet. Applicator is prefilled with vaginal ointment.
While firmly holding the purple-capped end of the applicator, push the tip of the plunger into the base of applicator.

REMOVE PURPLE CAP from top of applicator with a pull-twist action.

Insert the applicator

Lie on your back with your knees bent. Gently insert applicator into the vagina as far as it will go comfortably.
Push the plunger into the applicator until it will go no farther. Withdraw the applicator and plunger and dispose of it in the wastebasket. Do not flush.
DO NOT USE TAMPONS while using this medicine. Use sanitary napkins instead.

PLEASE READ EDUCATIONAL BROCHURE FOR ADDITIONAL INFORMATION.

4260000 P6

DISTRIBUTED BY

PERRIGO

ALLEGAN, MI 48010 U.S.A.

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

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