MONISTAT 1 COMBINATION PACK- miconazole nitrate 
Insight Pharmaceuticals

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Monistat® 1 Combination Pack

Drug Facts

Active ingredientsPurpose
Miconazole nitrate 1200 mg (in vaginal insert)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

Questions?

call toll-free 877-666-4782

Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053

PRINCIPAL DISPLAY PANEL - Kit Carton

1 DAY TREATMENT • OVULE® INSERT

MONISTAT® 1
Miconazole Nitrate Vaginal Insert (1200mg) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL

CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF

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

COMBINATION PACK

# 1 DOCTOR
RECOMMENDED BRAND

Net Wt. 1 OVULE® Insert • 0.32oz (9g) tube

Principal Display Panel - Kit Carton
MONISTAT 1 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-014
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-014-031 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH
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 Nitrate1200 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Mineral Oil (UNII: T5L8T28FGP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130806/29/2001
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130806/29/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02130806/29/2001
Labeler - Insight Pharmaceuticals (176792315)
Establishment
NameAddressID/FEIBusiness Operations
Jubilant246762764MANUFACTURE(63736-014)

Revised: 3/2013
Document Id: f4d0fb63-ff03-4d5a-9f11-2e04fbb0823b
Set id: 5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e
Version: 2
Effective Time: 20130305
 
Insight Pharmaceuticals