FDA Label for Miconazole 7

Other

Drug Facts

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

Relabeled By: Preferred Pharmaceuticals Inc.

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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

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
• •if you do not get complete relief ask a doctor before using another product

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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. Wash applicator 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: unscrew cap, lift tab, and pull to remove foil seal prior to use
• •do not use if foil seal on tube opening is broken or missing
• •do not purchase if carton is open
• •store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
• •before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

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

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel - 45 G Tube Carton

NDC 68788-7917-4

*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
Relieves associated external itching and irritation

Net wt. 1.59 oz (45 g) Tube
7 day vaginal cream (1 tube) with 1 reusable applicator

H²pharma

Relabeled By: Preferred Pharmaceuticals Inc.

Miconazole Nitrate Vaginal Cream 2% - miconazole 01