MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS- miconazole nitrate 
Insight Pharmaceuticals LLC

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Monistat 7 Cure Itch Relief - PreFilledApps-Cream

MONISTAT 7 COMBINATION PACK  7-DAY PRE-FILLED APPLICATORS- miconazole nitrate  
Insight Pharmaceuticals

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MONISTAT® 7 Combination Pack

Drug Facts

Active ingredient

Miconazole nitrate (100 mg in each applicator)

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 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 disease (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 after 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® 7 
C O M B I N A T I O N  P A C K
Miconazole Nitrate Vaginal Cream (2%) and Miconazole Nitrate Vaginal Cream (2%)
VAGINAL ANTIFUNGAL

• CURES most vaginal YEAST INFECTIONS• Relieves associated external itching and irritation

VAGINAL CREAM
with 7 Disposable Applicators
plus External Cream for Itch Relief

Net Wt. 1.59 oz (45g)
+ 0.32 oz (9g) Tube

7-DAY 
TREATMENT
COMBINATION PACK

Cream 

7 Disposable Applicators plus External Cream for Itch Relief

TAMPER-EVIDENT UNIT
DO NOT USE IF SEAL OVER TYPE
HAS BEEN PUNCTURED.

If you have any 
questions or
comments, please call

1-877-MONISTAT
(1-877-666-4782)

Dist. by Insight Pharmaceuticals LLC. Tarrytown, NY 10591
A Prestige Consumer Healthcare company
©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
All rights reserved, MNUS1107

COMBINATION PACK

Miconazole Nitrate Vaginal Cream (2%) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL

VAGINAL CREAM

with 7 Disposable Applicators                    Net Wt. 1.59 oz. (45g)

plus External Cream for Itch Relief                 + 0.32 oz. (9g) tube

label

MONISTAT 7 COMBINATION PACK  7-DAY PRE-FILLED APPLICATORS
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-023
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-023-151 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product04/23/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 17 TUBE, WITH APPLICATOR 35 g
Part 21 TUBE 9 g
Part 1 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
15 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01745004/26/1993
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
NDANDA01745004/26/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01745004/23/2020
Labeler - Insight Pharmaceuticals LLC (055665422)
Registrant - Apex International Mfg., Inc. (079110793)
Establishment
NameAddressID/FEIBusiness Operations
Apex International Mfg., Inc.079110793manufacture(63736-023)

Revised: 7/2020
Document Id: 80c7d48e-c1df-4d61-a801-50f4aee2ee63
Set id: 9b1ac735-9b18-48c2-86dc-93d07157d5e5
Version: 3
Effective Time: 20200709
 
Insight Pharmaceuticals LLC