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Miconazole 7

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 2g in 100g
Labeler: Exchange Select
NDC Code: 55301-730

Miconazole 7 Cream

Drug Facts

Active Ingredient

Miconazole nitrate, USP 2% (100 mg in each applicator)

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

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:
    applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use.
    use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to 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
  • to open tube use cap to puncture seal
  • do not use if seal over tube opening has been punctured or is not visible
  • do not purchase if carton is open
  • store at room temperature 15º - 30ºC (59º - 86ºF), avoid heat (over 30ºC or 86ºF).

Inactive Ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

exchange select TM

Compare to the active ingredient in Monistat® 7 Vaginal Cream*

MICONAZOLE 7
Miconazole Nitrate Vaginal Cream, USP 2%
(Miconazole Nitrate 100 mg per applicator)
VAGINAL ANTIFUNGAL

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

7 Day Vaginal Cream (1 Tube)
with 7 Disposable Applicators
Net Wt 1.59 oz (45 g)

Carton Image 1

 

Carton Image 2

MICONAZOLE 7 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-730
Route of AdministrationVAGINALDEA 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 
MINERAL OIL 
PEG-5 OLEATE 
PEGOXOL 7 STEARATE 
WATER 
Product Characteristics
ColorWHITE (white to off-white, viscous) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55301-730-417 TUBE (7 APPLICATOR) in 1 CARTON
145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416407/12/2002
Labeler - Exchange Select (001695568)
Establishment
NameAddressID/FEIOperations
Actavis Mid Atlantic LLC809515898ANALYSIS(55301-730), MANUFACTURE(55301-730)

Revised: 03/2013
 
Exchange Select

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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