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good sense miconazole 1

Dosage form: kit
Ingredients: MICONAZOLE NITRATE 1200mg; MICONAZOLE NITRATE 2g in 100g
Labeler: L Perrigo Company
NDC Code: 0113-0916

Perrigo Miconazole 1 Drug Facts

Active ingredient

Miconazole nitrate 1200 mg (in vaginal insert)

Miconazole nitrate 2% (external cream)

Purpose

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. (1-800-222-1222)

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. 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 vaginal insert blister is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured or cannot be seen
  • 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.
  • see end panel for lot number and expiration date

Inactive ingredients
  • vaginal insert: fractionated coconut oil, gelatin, glycerin, lecithin, light mineral oil, purified water, titanium dioxide, white petrolatum
  • external cream: benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

1 Day Treatment

Combination Pack

1 Softgel Insert with 1 Applicator

Plus external cream for Itch Relief

Softgel Insert

Fast Relief with less mess

Daytime-or-Nighttime

Stays in Place

1 Day Treatment

Miconazole 1

Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%)

Vaginal Antifungal

1 Softgel Insert with 1 Applicator Plus External Cream

Combination Pack

(Miconazole Nitrate 1200 mg per softgel plus 2% external vulvar cream)

Cures Most Vaginal Yeast Infections And Relieves Associated External Itching and Irritation

Compare to active ingredients of Monistat® 1 Combination Pack

Miconazole 1 Carton

GOOD SENSE MICONAZOLE 1 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0916
Packaging
#Item CodePackage Description
1NDC:0113-0916-001 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 TUBE 9 g
Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate insert
Product Information
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE1200 mg
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES 
GELATIN 
GLYCERIN 
LIGHT MINERAL OIL 
WATER 
TITANIUM DIOXIDE 
PETROLATUM 
Packaging
#Item CodePackage Description
11 INSERT (INSERT) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA079114
Part 2 of 2
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
GLYCERYL MONOSTEARATE 
MINERAL OIL 
WATER 
Packaging
#Item CodePackage Description
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA079114
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911406/29/2010
Labeler - L Perrigo Company (006013346)

Revised: 06/2010
 
L Perrigo Company

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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