MONISTAT TIOCONAZOLE 1- tioconazole ointment 
Insight Pharmaceuticals LLC

----------

Monistat Tioconazole Ointment

Drug Facts

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Uses

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 the 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 diseases (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
  • if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if:

  • symptoms do not get better in 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 (1-800-222-1222).

Directions

Other information

Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions?

1-877-666-4782

PRINCIPAL DISPLAY PANEL

MONISTAT®

Tioconazole Ointment 6.5%

VAGINAL ANTIFUNGAL

Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR

PRINCIPAL DISPLAY PANEL
MONISTAT®
Tioconazole Ointment 6.5%
VAGINAL ANTIFUNGAL

Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR

MONISTAT TIOCONAZOLE 1 
tioconazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-413
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117) TIOCONAZOLE6.5 g  in 100 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:63736-413-011 in 1 CARTON11/21/2001
14.6 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07591511/21/2001
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 3/2019
Document Id: c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df
Set id: 587e42b4-cbdc-4a03-afae-f9e5e6605937
Version: 1
Effective Time: 20190319
 
Insight Pharmaceuticals LLC