MONISTAT 3 COMBINATION PACK- miconazole nitrate 
Insight Pharmaceuticals

----------

MONISTAT®3
COMBINATION PACK

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream
(2%)
Vaginal Antifungal

DRUG FACTS

Active ingredientsPurpose
Miconazole nitrate (200 mg in each suppository)Vaginal antifungal
Miconazole nitrate 2% (external cream)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

suppository: hydrogenated vegetable oil base

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
Visit our website @ www.monistat.com

PRINCIPAL DISPLAY PANEL - Kit Carton

3 DAY TREATMENT • SOFT INSERTS

MONISTAT® 3
Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Cream (2%)
(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)
VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritation

CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF

COMBINATION PACK

Net Wt. 3 Suppositories • 0.32 oz. (9g) tube

Principal Display Panel - Kit Carton
MONISTAT 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-016
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-016-031 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 TUBE 9 g
Part 1 of 2
MONISTAT 3 
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
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067004/16/1996
Part 2 of 2
MONISTAT 3 
miconazole nitrate cream
Product Information
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate10 mg  in 0.5 g
Inactive Ingredients
Ingredient NameStrength
benzoic acid (UNII: 8SKN0B0MIM)  
cetyl alcohol (UNII: 936JST6JCN)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
polysorbate 60 (UNII: CAL22UVI4M)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
19 g in 1 TUBE
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 (176792315)
Establishment
NameAddressID/FEIBusiness Operations
Jubilant246762764MANUFACTURE(63736-016)

Revised: 8/2012
Document Id: adba15db-7324-4621-be60-71a8b1f895df
Set id: 7a138851-eb37-4ca3-909f-46492c844950
Version: 2
Effective Time: 20120802
 
Insight Pharmaceuticals