Skip to Content

← See all Monistat 1 Combination Pack brands

Monistat 1 Combination Pack by Insight Pharmaceuticals

Dosage form: kit
Ingredients: Miconazole Nitrate 1200mg; Miconazole Nitrate 20mg in 1g
Labeler: Insight Pharmaceuticals
NDC Code: 63736-014

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
  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

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
  • before using this product read the enclosed consumer information leaflet for complete directions and information
  • adults and children 12 years of age and over:
    • vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away after use.
    • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days, as needed.
  • children under 12 years of age: ask a doctor

Other information
  • do not use if printed sealed pouch is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F)
  • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.

Inactive ingredients
  • vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum
  • external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

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

MONISTAT 1 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-014
Packaging
#Item CodePackage Description
1NDC:63736-014-031 KIT 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 AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate1200 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin 
Glycerin 
Mineral Oil 
Titanium Dioxide 
Petrolatum 
Packaging
#Item CodePackage Description
11 SUPPOSITORY 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 AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate20 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
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/FEIOperations
Jubilant246762764MANUFACTURE(63736-014)

 
Insight Pharmaceuticals

← See all Monistat 1 Combination Pack brands

Medically reviewed on Mar 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide