Good Neighbor Tioconazole 1

Generic Name: tioconazole
Dosage Form: vaginal ointment

Amerisource Bergen Tioconazole 1 Drug Facts

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

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Purpose

Vaginal antifungal

Uses

  • treats vaginal yeast infections

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 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

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.

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 or comments?

1-800-719-9260

Principal Display Panel

Compare to active ingredient in 1-Day™

Tioconazole 1

Tioconazole Ointment, 6.5%

Vaginal Antifungal

Cures Most Vaginal Yeast Infections

1-Dose Treatment

Educational Brochure Enclosed

# Prefilled Applicator

Tioconazole 1 Carton

GOOD NEIGHBOR PHARMACY TIOCONAZOLE 1 
tioconazole ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-374
Route of Administration VAGINAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIOCONAZOLE (TIOCONAZOLE) TIOCONAZOLE 6.5 g  in 100 g
Product Characteristics
Color BROWN (light to dark tan) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:24385-374-82 1 APPLICATOR (APPLICATOR) in 1 CARTON
1 4.6 g in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075915 02/20/2008
Labeler - Amerisource Bergen (007914906)
Revised: 11/2009
 
Amerisource Bergen



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