Miconazole Nitrate

Rebel Distributors Corp

Miconazole Nitrate 2% Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Keep Out of Reach of Children
• Miconazole Nitrate Uses
• Warnings
• Other Information
• Directions
• Inactive ingredients
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Miconazole Nitrate 2% (100 mg in each applicator)

Purpose

Vaginal antifungal

Keep Out of Reach of Children

If swallowed, get medical help or contact a
Poison Control Center right away.

Miconazole Nitrate Uses

. treats repeat vaginal yeast infections
. relieves external itching and irritation due to a repeat vaginal yeast infection

Warnings

For vaginal use only
Ask a doctor before use if you have
. never had a vaginal yeast infection diagnosed by a doctor
. 1 or more of the following:
abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge
. vaginal yeast infections often (such as once a month or 3 in 6 months)
. 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 abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge, or rash
If pregnant or breast-feeding, ask a health professional before use.

Other Information

. do not purchase if printed "Safety Sealed" carton
overwrap is broken or missing
. 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.

Directions

. 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

Inactive ingredients

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

Package/Label Principal Display Panel