MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS- miconazole nitrate 
Insight Pharmaceuticals LLC

----------

MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS

Drug Facts

Active ingredients

Miconazole nitrate (200 mg in each vaginal insert)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

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

Ask a doctor or pharmacist before use if you are

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

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.

Directions

Other information

Inactive ingredients

vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

If you have any questions or comments, please call 1-877-666-4782 

PRINCIPAL DISPLAY PANEL

MONISTAT® 3 COMBINATION PACK

Miconazole Nitrate Vaginal Inserts (200 mg) and Miconazole Nitrate Vaginal Cream (2%)

VAGINAL ANTIFUNGAL

3 OVULE® Inserts with 3 Applicators (Net Wt. 3 OVULE® Inserts)

plus External Cream for Itch Relief (0.32 oz (9 g) Tube

PRINCIPAL DISPLAY PANEL
MONISTAT® 3 COMBINATION PACK
Miconazole Nitrate Vaginal Inserts (200 mg) and Miconazole Nitrate Vaginal Cream (2%) 
VAGINAL ANTIFUNGAL

3 OVULE® Inserts with 3 Applicators (Net Wt. 3 OVULE® Inserts) 
plus External Cream for Itch Relief (0.32 oz (9 g) Tube

MONISTAT 3 COMBINATION PACK  3 OVULE INSERTS
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-019
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-019-031 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product04/16/1996
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 KIT
Part 21 TUBE 9 g
Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate suppository
Product Information
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate200 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 in 1 KIT; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/16/1996
Part 2 of 2
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid (UNII: 8SKN0B0MIM)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
19 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/16/1996
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/16/1996
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 2/2019
Document Id: 4233bca3-1637-4e7c-8af2-2ed6e98730e3
Set id: 910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd
Version: 2
Effective Time: 20190215
 
Insight Pharmaceuticals LLC