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Miconazole Nitrate by A-S Medication Solutions

Medically reviewed on October 6, 2017

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: A-S Medication Solutions
NDC Code: 50090-0462

Miconazole Nitrate Vaginal Cream 2 %
7 Day Vaginal Cream

ACTIVE INGREDIENT

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)

PURPOSE

Vaginal antifungal

USES

• treats repeat vaginal yeast infections
• relieves external itching and irritation due to a repeat 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 medication warfarin, because bleeding or bruising may occur.

When using this product
• do not use tampons, douches, spermicides, or other vaginal products
• do not have vaginal intercourse
• condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)

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.

DOSAGE & ADMINISTRATION

• before using this product read the enclosed consumer information leaflet for complete instructions
• adults and children 12 years of age and over:
         • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
         • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated  
             skin outside the vagina. Use daily for up to 7 days as needed
• children under 12 years of age: ask a doctor

OTHER INFORMATION

• do not use if seal over tube opening has been punctured or cannot be seen
• store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.

INACTIVE INGREDIENT

benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

HOW SUPPLIED

Product: 50090-0462

NDC: 50090-0462-0 45 g in a TUBE, WITH APPLICATOR

QUESTIONS

1-800-922-1038

Miconazole Nitrate
MICONAZOLE NITRATE  
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0462(NDC:0713-0252)
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 
Butylated Hydroxyanisole 
Mineral Oil 
Peg-5 Oleate 
Pegoxol 7 Stearate 
Water 
Packaging
#Item CodePackage Description
1NDC:50090-0462-0 45 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07436602/22/1996
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-0462)

 
A-S Medication Solutions

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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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