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Miconazole 7 by Preferred Pharmaceuticals, Inc.

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Preferred Pharmaceuticals, Inc.
NDC Code: 68788-9772

Miconazole Nitrate Vaginal Cream

ACTIVE INGREDIENT

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as 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
•vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
•lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
•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
•do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
•do not have vaginal intercourse (sex)
•mild increase in vaginal burning or irritation may occur

STOP USE AND ASK A DOCTOR IF
•symptoms do not get better after 3 days
•symptoms last more than 7 days
•you get a rash, 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 the Poison Control Center right away.

DIRECTIONS
•before using this product read the enclosed brochure for complete instructions
adults and children 12 years of age and over:
applicator: insert one applicatorful into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
external cream:  squeeze a small amount of cream onto your fingertip.  Gently 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:  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 INGREDIENTS

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

QUESTIONS?

1-800-922-1038

HOW SUPPLIED

Miconazole Nitrate Vaginal Cream USP 2%

45gr – NDC 68788-9772-4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MICONAZOLE 7 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9772(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:68788-9772-41 TUBE, WITH APPLICATOR in 1 CARTON
145 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416407/27/2012
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9772)

 
Preferred Pharmaceuticals, Inc.

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Medically reviewed on Dec 14, 2017

Further information

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

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