Miconazole 7

Preferred Pharmaceuticals, Inc.

Miconazole Nitrate Vaginal Cream

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTIVE INGREDIENT
• PURPOSE
• USES
• WARNINGS
• DO NOT USE
• ASK A DOCTOR BEFORE USE IF YOU HAVE
• ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
• WHEN USING THIS PRODUCT
• STOP USE AND ASK A DOCTOR IF
• IF PREGNANT OR BREAST-FEEDING
• KEEP OUT OF REACH OF CHILDREN.
• DIRECTIONS
• INACTIVE INGREDIENTS
• QUESTIONS?
• HOW SUPPLIED
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

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