MICONAZOLE 3 COMBINATION PACK - miconazole nitrate   
Cardinal Health

----------

Miconazole Nitrate Vaginal Suppositories (Disposable Applicator)

ACTIVE INGREDIENTS

Miconazole nitrate (200 mg in each suppository)

Miconazole nitrate 2% (external cream)

PURPOSE

Vaginal antifungal

USES

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

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

STOP USE AND ASK A DOCTOR IF

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.

DIRECTIONS

Other Information

INACTIVE INGREDIENTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-583-03

LEADER®

Compare to Monistat® 3 active ingredient*

Miconazole 3

Combination Pack

Miconazole Nitrate Vaginal Suppositories USP, 200 mg and Miconazole Nitrate External Vulvar Cream, 2%

VAGINAL ANTIFUNGAL

Cures most vaginal yeast infections

Relieves associated external itching and irritation

3 Vaginal suppositories with 3 disposable applicators plus external cream

NET WT. 0.32 oz (9 g) tube

ee5df4e6-figure-01
ee5df4e6-figure-02

3 DISPOSABLE APPLICATORS CARTON LABEL

EDUCATIONAL BROCHURE

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP, 200 mg and

MICONAZOLE NITRATE EXTERNAL VULVAR CREAM, 2%

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS

RELIEVES EXTERNAL VULVAR ITCHING AND IRRITATION ASSOCIATED WITH A YEAST INFECTION

INDICATIONS

For the treatment of vaginal yeast infections and the relief of external vulvar itching and irritation associated with a yeast infection.

If you have any or all of the symptoms of a vaginal yeast infection (vaginal itching, burning, discharge) accompanied by external vulvar itching and irritation and if at some time in the past your doctor has told you that these symptoms are due to a vaginal yeast infection, then Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate External Vulvar Cream should work for you. If, however, you have never had these symptoms before, you should see your doctor before using these products.

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES and MICONALZOLE NITRATE EXTERNAL VULVAR CREAM ARE FOR THE TREATMENT OF VAGINAL YEAST INFECTIONS AND FOR THE RELIEF OF EXTERNAL VULVAR ITCHING AND IRRITATION ASSOCIATED WITH A YEAST INFECTION. THESE PRODUCTS DO NOT TREAT OTHER INFECTIONS OR EXTERNAL ITCHING AND IRRITATION DUE TO CAUSES OTHER THAN YEAST INFECTIONS. THESE PRODUCTS DO NOT PREVENT PREGNANCY.

WHAT ARE VAGINAL YEAST INFECTIONS (CANDIDIASIS)?

A yeast infection is a common type of vaginal infection. Your doctor may call it candidiasis. This condition is caused by an organism called Candida, which is a type of yeast. Even healthy women usually have this yeast on the skin, in the mouth, in the digestive tract, and in the vagina. At times, the yeast can grow very quickly. In fact, the infection is sometimes called yeast (Candida) “overgrowth”.  Some women also experience a yeast infection on the external skin (vulva) associated with the internal vaginal infection.

A yeast infection can occur at almost any time of life. It is most common during the childbearing years. The infection tends to develop most often in some women who are pregnant, diabetic, taking antibiotics, taking birth control pills, or have a damaged immune system.

Various medical conditions can damage the body’s normal defenses against infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV – the virus that causes AIDS). Infection with HIV causes the body to be more susceptible to infections, including vaginal yeast infections. Women with HIV infection may have frequent vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment. If you may have been exposed to HIV and are experiencing either frequently recurring vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment, you should see your doctor promptly. If you wish further information on risk factors for HIV infection, or on the relationship between recurrent or persistent vaginal yeast infections and HIV infection, please contact your doctor or the CDC National AIDS HOTLINE at 1-800-342-AIDS (English), 1-800-344-7432 (Spanish), or 1-800-243-7889 (Hearing Impaired, TDD).

IF YOU EXPERIENCE FREQUENT YEAST INFECTIONS (THEY RECUR WITHIN A TWO MONTH PERIOD) OR IF YOU HAVE YEAST INFECTIONS THAT DO NOT CLEAR UP EASILY WITH PROPER TREATMENT, YOU SHOULD SEE YOUR DOCTOR PROMPTLY TO DETERMINE THE CAUSE AND TO RECEIVE PROPER MEDICAL CARE.

SYMPTOMS OF VAGINAL YEAST INFECTIONS

There are many signs and symptoms of a vaginal yeast infection. They can include:

NOTE: Vaginal discharge that is different from above, for example, a yellow/green discharge or a discharge that smells “fishy”, may indicate that you have something other than a yeast infection. If this is the case, you should consult your doctor before using these products.

WARNINGS

CONTENTS

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP: Three vaginal suppositories each containing 200 mg of miconazole nitrate.

MICONAZOLE NITRATE EXTERNAL VULVAR CREAM: One tube of cream for external vulvar use containing miconazole nitrate 2%.

PLASTIC APPLICATORS: Your combination pack contains either one reusable plastic applicator or three disposable plastic applicators.

DIRECTIONS FOR USE

Miconazole Nitrate Vaginal Suppositories

Begin treatment at bedtime. Before going to bed:

  1. Tear off one suppository from the strip. Separate the plastic wrap at the pointed end with your thumb. With thumb and forefinger of each hand, hold the plastic tabs and pull apart (see picture). Gently remove the suppository from the plastic wrap.
    ee5df4e6-figure-03
  2. Place suppository in the top of the applicator as shown.
    ee5df4e6-figure-04
  3. Hold the applicator containing the suppository by the opposite end from where the suppository is. Gently insert the applicator into the vagina as far as it will go comfortably. As shown in the pictures, this can be done while standing with your feet spread a few inches apart and your knees bent. Or, you can lie on your back with your knees bent. Once you are ready, push the inside piece of the applicator in and place the suppository as far back in the vagina as possible. Then remove the applicator from the vagina. You should go to bed as soon as possible after inserting the suppository. This will keep leakage to a minimum.
    ee5df4e6-figure-05

    You may want to use deodorant-free mini-pads or pantyshields during the time that you are using miconazole nitrate vaginal suppositories. This is because the suppository can leak. DO NOT USE TAMPONS.

  4. Be sure to clean the reusable plastic applicator after each use. Pull the two pieces apart. Wash them with soap and warm water. To rejoin, gently push the inside piece into the outside piece as far as it will go.
    ee5df4e6-figure-06
  5. Repeat steps 1 through 4 before going to bed on each of the next two evenings.

Miconazole Nitrate External Vulvar cream

Use the cream twice daily if needed as follows:

  1. Open the tube. To do this, unscrew the cap, turn the cap upside down and place the cap in the end of the tube. Push down firmly until the seal is broken (as shown).
    ee5df4e6-figure-07
  2. Squeeze a small amount of cream onto your finger.
  3. Gently apply the cream onto the skin (vulva) that itches and is irritated.
  4. Repeat steps 2 and 3 each morning and evening as needed.

ADVERSE REACTIONS (SIDE EFFECTS)

The following side effects have been reported with the use of Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate External Vulvar Cream: a temporary increase in burning, itching, and/or irritation when the suppository is inserted. Abdominal cramping, headaches, hives, and skin rash have also been reported. If any of these occur, stop using these products and consult your doctor.

FOR BEST RESULTS

  1. Be sure to use all of the suppositories even if your symptoms go away before you have used all the suppositories.
  2. Use one suppository at bedtime for three nights in a row, even during your menstrual period.
  3. Wear cotton underwear.
  4. If your partner has any penile itching, redness, or discomfort, he should consult his doctor and mention that you are treating yourself for a vaginal yeast infection.
  5. Dry the outside vaginal area thoroughly after a shower, bath or swim. Change out of a wet bathing suit or damp workout clothes as soon as possible. A dry area is less likely to encourage the growth of yeast.
  6. Wipe from front to rear (away from the vagina) after a bowel movement or urination.
  7. Do not douche unless your doctor tells you to do so. Douching may disturb the vaginal bacterial balance.
  8. Do not scratch if you can help it. Scratching can cause more irritation and can spread the infection.
  9. Discuss with your doctor any medication you are now taking. Certain types of medication can make your vagina more prone to infection.

IF YOU HAVE A QUESTION

1-800-432-8534 (select option #2)

Questions of a medical nature should be taken up with your doctor.

ACTIVE INGREDIENTS

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP - miconazole nitrate (200 mg each suppository).

MICONAZOLE NITRATE EXTERNAL VULVAR CREAM – miconazole nitrate 2%.

STORAGE

Store at room temperature 59( - 86(F (15( - 30(C). Avoid heat (over 86(F or 30(C).

Manufactured by:

Actavis Mid Atlantic LLC

1877 Kawai Road,

Lincolnton NC 28092 USA

FORM NO. 7310

Rev. 8/08

VC3336

MICONAZOLE 3 COMBINATION PACK 
miconazole nitrate kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-583
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-583-031 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 TUBE 9 g
Part 1 of 2
MICONAZOLE NITRATE 
miconazole nitrate suppository
Product Information
Item Code (Source)NDC:37205-583
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE200 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA074926
Part 2 of 2
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Item Code (Source)NDC:37205-583
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE10 mg  in 0.5 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
MINERAL OIL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
19 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA074926
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07492612/02/2002
Labeler - Cardinal Health (097537435)

Revised: 12/2011
Document Id: ee5df4e6-15af-4234-b49a-76b39e8b7965
Set id: 79b61ece-7590-4448-86fa-28ab3d3cc074
Version: 1
Effective Time: 20111227
 
Cardinal Health