Tioconazole 1 Day

Dosage form: ointment
Ingredients: Tioconazole 300mg in 1g
Labeler: Insight Pharmaceuticals LLC
NDC Code: 63736-410

1-DAY Tioconazole Ointment 6.5%

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)

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

TIOCONAZOLE  1 DAY
tioconazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-410
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tioconazole (Tioconazole) Tioconazole300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
butylated hydroxyanisole 
magnesium aluminum silicate 
petrolatum 
Packaging
#Item CodePackage Description
1NDC:63736-410-011 POUCH in 1 CARTON
11 APPLICATOR in 1 POUCH
14.6 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07591511/21/2001
Labeler - Insight Pharmaceuticals LLC (176792315)
Establishment
NameAddressID/FEIOperations
Perrigo006013346MANUFACTURE(63736-410)

Revised: 07/2012
 
Insight Pharmaceuticals LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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