Up and Up Tioconazole 1

Generic Name: tioconazole
Dosage Form: vaginal ointment

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Target Corp. 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?

1-800-910-6874

Principal Display Panel

1-Dose Treatment

Tioconazole 1

Tioconazole Ointment 6.5%

Vaginal Antifungal

Compare to active ingredient in 1-Day™

Cures Most Vaginal Yeast Infections

1 Ready-to-Use Prefilled Applicator

Educational Brochure Enclosed

1 Dose

Tioconazole 1 Carton

Up and Up Tioconazole 1
tioconazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11673-426
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:11673-426-54	1 POUCH (POUCH) in 1 CARTON
1		1 APPLICATOR (APPLICATOR) in 1 POUCH
1		4.6 g in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075915	07/08/2009

Labeler - Target Corporation (006961700)

Revised: 11/2009

Target Corporation

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Vaginal Yeast Infection