TIOCONAZOLE 1 DAY- tioconazole ointment 
Insight Pharmaceuticals LLC

----------

1-DAY Tioconazole Ointment 6.5%

Drug Facts

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Use

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

Other information

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

PRINCIPAL DISPLAY PANEL - 4.6g Applicator Carton
TIOCONAZOLE  1 DAY
tioconazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tioconazole (UNII: S57Y5X1117) (Tioconazole - UNII:S57Y5X1117) Tioconazole300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
butylated hydroxyanisole (UNII: REK4960K2U)  
magnesium aluminum silicate (UNII: 6M3P64V0NC)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-410-011 in 1 CARTON
11 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/FEIBusiness Operations
Perrigo006013346MANUFACTURE(63736-410)

Revised: 7/2012
Document Id: 561d72af-1eae-4009-8576-afc274365166
Set id: 41258b67-6ce7-48f1-9787-6824902cb203
Version: 1
Effective Time: 20120702
 
Insight Pharmaceuticals LLC