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Monistat 3 Combination Pack by Physicians Total Care, Inc.

Medically reviewed on Apr 2, 2018

Dosage form: kit
Ingredients: Miconazole Nitrate 200mg; Miconazole Nitrate 10mg in 0.5g
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-4238

MONISTAT®3
COMBINATION PACK

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

DRUG FACTS

Active ingredientsPurpose
Miconazole nitrate (200 mg in each suppository)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:
  • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away 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 blister is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured or embossed design is not visible

  • do not purchase if carton is open
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

suppository: hydrogenated vegetable oil base

external cream: 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
Visit our website @ www.monistat.com

PRINCIPAL DISPLAY PANEL

54868-4238-0

MONISTAT® 3
COMBINATION PACK

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

(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)

CURES MOST VAGINAL YEAST INFECTIONS

AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

3 Vaginal Suppositories with Disposable
Applicators
plus External Cream

Net Wt. 3 Suppositories
0.32 oz (9g) tube




Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma     74146
MONISTAT 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-4238(NDC:30014-016)
Packaging
#Item CodePackage Description
1NDC:54868-4238-01 KIT (KIT) in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 TUBE 9 g
Part 1 of 2
MONISTAT 3 
miconazole nitrate suppository
Product Information
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate200 mg
Inactive Ingredients
Ingredient NameStrength
corn oil 
Packaging
#Item CodePackage Description
13 SUPPOSITORY (SUPPOSITORY) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067003/27/2012
Part 2 of 2
MONISTAT 3 
miconazole nitrate cream
Product Information
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate10 mg  in 0.5 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
NDANDA02067003/27/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02067003/27/2012
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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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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