Monistat 3 3-Day Pre-filled Applicators

Dosage form: cream
Ingredients: Miconazole Nitrate 40mg in 1g
Labeler: Insight Pharmaceuticals
NDC Code: 63736-015

Monistat® 3 Day Vaginal Cream in Prefilled Applicators

Drug Facts

Active ingredient

Miconazole nitrate 4% (200 mg in each applicatorful)

Purpose

Vaginal antifungal

Use
  • treats vaginal yeast infections

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
  • before using this product read the enclosed consumer information leaflet for complete directions and information
  • adults and children 12 years and over:
    • applicators: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
  • children under 12 years of age: ask a doctor

Other information
  • do not use if printed applicator wrapper is torn, open or incompletely sealed
  • do not purchase if carton is open
  • store at 20° - 25°C (68° to 77°F)

Inactive ingredients

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

Call toll-free 877-666-4782 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

3 DAY TREATMENT • CREAM

MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)
(Miconazole Nitrate 200 mg per applicator)
VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS

CLINICALLY PROVEN
3 DAY TREATMENT

CLASSIC

#1 DOCTOR
RECOMMENDED BRAND

Net Wt. 0.18 oz. (5g) each applicator

MONISTAT 3   3-DAY PRE-FILLED APPLICATORS
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-015
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid 
Cetyl Alcohol 
Isopropyl Myristate 
Polysorbate 60 
Potassium Hydroxide 
Propylene Glycol 
Water 
Stearyl Alcohol 
Packaging
#Item CodePackage Description
1NDC:63736-015-183 TUBE, WITH APPLICATOR in 1 CARTON
15 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02082703/30/1998
Labeler - Insight Pharmaceuticals (176792315)
Establishment
NameAddressID/FEIOperations
Jubilant246762764MANUFACTURE(63736-015)

Revised: 04/2014
 
Insight Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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