FDA Label for Tioconazole 1 Day

Other

Drug Facts

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

Active Ingredient (In Each Applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Use

• treats vaginal yeast infections

Otc - Do Not Use

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

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

Otc - Keep Out Of Reach Of Children

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 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
  
  

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)

Principal Display Panel - 4.6G Applicator Carton

1 DAY TREATMENT • PREFILLED APPLICATOR

1-DAY
Tioconazole Ointment 6.5%
VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS

CLINICALLY PROVEN
1 DAY TREATMENT

Net Wt. 4.6g (0.16oz) filled applicator

PRINCIPAL DISPLAY PANEL - 4.6g Applicator Carton - tioconazole 01