MONISTAT TIOCONAZOLE 1- tioconazole ointment

MONISTAT TIOCONAZOLE 1 by

Drug Labeling and Warnings

MONISTAT TIOCONAZOLE 1 by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

• before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
  
• adults and children 12 years of age and over:
  ○ open the foil packet just before use and remove purple cap
  ○ insert entire content 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 get complete relief of their symptoms in just one day. Most women get some improvement in 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?

1-877-666-4782

PRINCIPAL DISPLAY PANEL

MONISTAT®

Tioconazole Ointment 6.5%

VAGINAL ANTIFUNGAL

Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR

INGREDIENTS AND APPEARANCE

MONISTAT TIOCONAZOLE 1 
tioconazole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117)	TIOCONAZOLE	6.5 g  in 100 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: 63736-413-01	1 in 1 CARTON	11/21/2001
1		4.6 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075915	11/21/2001

Labeler - Insight Pharmaceuticals LLC (055665422)