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sunmark miconazole 3 by McKesson

Medically reviewed on February 12, 2018

Dosage form: kit
Ingredients: MICONAZOLE NITRATE 200mg; MICONAZOLE NITRATE 2g in 100g
Labeler: McKesson
NDC Code: 49348-354

McKesson Miconazole 3 Drug Facts

Active ingredient

Miconazole nitrate (200 mg in each suppository)

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 a prescription blood thinning medicine, such as 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

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 instructions and information
  • adults and children 12 years of age and over:
  • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Wash applicator 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 suppository wrapper is missing or damaged (each suppository is individually wrapped)
  • 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)

Inactive ingredients

suppository: hydrogenated vegetable oil

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

Compare to Monistat® 3 Combination Pack Active Ingredients

3 Day Treatment with Reusable Applicator

Miconazole 3

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Cream (2%)

Vaginal Antifungal

Combination Pack

Cures most vaginal yeast infections and relieves associated external itching & irritation

(Miconazole Nitrate 200 mg per Suppository Plus 2% External Vulvar Cream)

3 Vaginal Suppositories with Reusable Applicator plus External Vulvar Cream

Miconazole 3 Carton Image 1

Miconazole 3 Carton Image 2

SUNMARK MICONAZOLE 3 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-354
Packaging
#Item CodePackage Description
1NDC:49348-354-431 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 suppository
Product Information
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE200 mg
Product Characteristics
ColorWHITE (white to off white; opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
13 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA075329
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 
Product Characteristics
ColorWHITE (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA075329
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07532909/05/2003
Labeler - McKesson (177667227)

 
McKesson

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Further information

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

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