GOOD NEIGHBOR PHARMACY TIOCONAZOLE 1 - tioconazole ointment 
Amerisource Bergen

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Amerisource Bergen Tioconazole 1 Drug Facts

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

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

GOOD NEIGHBOR PHARMACY TIOCONAZOLE 1  tioconazole   ointment

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN (light to dark tan) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24385-374-82 1 APPLICATOR In 1 CARTON contains a APPLICATOR 1 4.6 g In 1 APPLICATOR This package is contained within the CARTON (24385-374-82)

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: 11/2009Amerisource Bergen