MONISTAT 7 7-DAY DISPOSABLE APPLICATORS- miconazole nitrate cream 
Insight Pharmaceuticals LLC

----------

Monistat 7 Simply - 7 dispos apps-Cream


Drug Facts

Active ingredient

Purpose

Miconazole nitrate 2% ……………….………………………………….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

MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)

Vaginal Antifungal

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

PRINCIPAL DISPLAY PANEL
MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%) 
Vaginal Antifungal
Net Wt. 1.59 oz. (45g) Tube + 7 Disposable Applicators

MONISTAT 7  7-DAY DISPOSABLE APPLICATORS
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-026
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
1NDC:63736-026-157 in 1 CARTON04/26/1993
145 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
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 3/2024
Document Id: 0e15c85d-6fd3-419d-bba3-40d10fe4ef99
Set id: c4b68aff-e95f-47ae-b190-6a671bef1877
Version: 5
Effective Time: 20240325
 
Insight Pharmaceuticals LLC