MONISTAT 3 COMBINATION PACK- miconazole nitrate 
Insight Pharmaceuticals LLC

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MONISTAT 3 Combination Pack - prefilled app and cream

DRUG FACTS

Active ingredients

Purpose

Miconazole nitrate 4%       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

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

- Kit Carton

MONISTAT® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%) - Vaginal Antifungal

3 PREFILLED APPLICATORS             Net Wt. 0.18 oz. (5g) +0.32 oz. (9g) tube 

PRINCIPAL DISPLAY PANEL
- Kit Carton
MONISTAT® 3
COMBINATION PACK
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%) - Vaginal Antifungal
3 PREFILLED APPLICATORS		Net Wt. 0.18 oz. (5g) +0.32 oz. (9g) tube

MONISTAT 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-010
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-010-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product12/10/2009
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 APPLICATOR 3 g
Part 21 TUBE 9 g
Part 1 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 NITRATE40 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)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067012/10/2009
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 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)  
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
NDANDA02067012/10/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067012/10/2009
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 5/2023
Document Id: 311a8a93-b525-4f05-a16a-6f29eb40303d
Set id: e1b8ad40-5adb-482a-b532-3f8e30d90128
Version: 3
Effective Time: 20230515
 
Insight Pharmaceuticals LLC