TIOCONAZOLE 1 DAY- tioconazole ointment

Tioconazole by

Drug Labeling and Warnings

Tioconazole by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC, Perrigo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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?

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

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

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

INGREDIENTS AND APPEARANCE

TIOCONAZOLE  1 DAY
tioconazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tioconazole (UNII: S57Y5X1117) (Tioconazole - UNII:S57Y5X1117)	Tioconazole	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
butylated hydroxyanisole (UNII: REK4960K2U)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-410-01	1 in 1 CARTON
1		1 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	11/21/2001

Labeler - Insight Pharmaceuticals LLC (176792315)

Establishment
Name	Address	ID/FEI	Business Operations
Perrigo		006013346	MANUFACTURE(63736-410)