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1-DAY Tioconazole Ointment 6.5%


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Drug Facts


Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)


Purpose

Vaginal antifungal


Use

  • treats vaginal yeast infections

Warnings


OTC - DO NOT USE SECTION

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 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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions

  • 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:open the foil packet just before use and remove purple capinsert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
  • children under 12 years of age: ask a doctor

Other information

  • this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within 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

Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum


Questions?

call toll-free 877-666-4782 or 215-273-8755 (collect)


SPL UNCLASSIFIED SECTION

Distributed by: INSIGHT Pharmaceuticals, LLC.Langhorne, PA 19047-1749