Miconazole Nitrate Vaginal Insert (1200Mg) and Miconazole Nitrate Cream (2%)

Questions? Questions?

If you have any questions or comments, please call 1-877-666-4782 call please comments, or questions any have you If mild increase in vaginal burning, itching or irritation may occur may irritation or itching burning, vaginal in increase mild

do not have vaginal intercourse intercourse vaginal have not do

hydroxide, propylene glycol, purified water, stearyl alcohol stearyl water, purified glycol, propylene hydroxide, diseases (STDs). diseases

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium potassium 60, polysorbate myristate, isopropyl alcohol, cetyl acid, benzoic cream: external diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted transmitted sexually or pregnancy prevent to fail and damaged be may diaphragms

gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum white dioxide, titanium oil, mineral lecithin, glycerin, gelatin, insert: vaginal

do not use tampons, douches, spermicides or other vaginal products. Condoms and and Condoms products. vaginal other or spermicides douches, tampons, use not do

Inactive ingredients Inactive

When using this product this using When

1 day. Most women get some improvement in 1 day and complete relief by 7 days. 7 by relief complete and day 1 in improvement some get women Most day. 1

medicine warfarin, because bleeding or bruising may occur may bruising or bleeding because warfarin, medicine

this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just in symptoms their of relief complete get not do women Most treatment. 1-dose a is this

taking the prescription blood thinning blood prescription the taking are you if use before pharmacist or doctor a Ask

F) F) -77 (68 C -25 20 at store ° ° ° °

do not purchase if carton is open open is carton if purchase not do

do not use if seal over tube opening has been punctured or embossed design is not visible not is design embossed or punctured been has opening tube over seal if use not do

been exposed to the human immunodeficiency virus (HIV) that causes AIDS causes that (HIV) virus immunodeficiency human the to exposed been

sealed pouch is torn, open or incompletely sealed sealed incompletely or open torn, is pouch sealed printed if use not do or a weakened immune system. immune weakened a or

Other information information Other

pregnant or have a serious underlying medical cause for your symptoms, including diabetes diabetes including symptoms, your for cause medical underlying serious a have or pregnant

vaginal yeast infections often (such as once a month or 3 in 6 months). You could be be could You months). 6 in 3 or month a once as (such often infections yeast vaginal

children under 12 years of age: ask a doctor a ask age: of years 12 under children

vaginal discharge. You may have a more serious condition. serious more a have may You discharge. vaginal days, as needed. as days,

lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling foul-smelling or vomiting, nausea, chills, fever, pain, shoulder or back abdominal, lower cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 7 to up for daily times 2 Use vagina. the outside skin irritated itchy, the onto cream

time first the for discomfort and itching vaginal

squeeze a small amount of cream onto your fingertip. Apply the the Apply fingertip. your onto cream of amount small a squeeze cream: external

Ask a doctor before use if you have you if use before doctor a Ask Throw applicator away after use. after away applicator Throw

with the applicator place the vaginal insert into the vagina. vagina. the into insert vaginal the place applicator the with insert: vaginal

if you have never had a vaginal yeast infection diagnosed by a doctor a by diagnosed infection yeast vaginal a had never have you if use not Do

adults and children 12 years of age and over: and age of years 12 children and adults

For vaginal use only use vaginal For directions and information and directions

before using this product read the enclosed consumer information leaflet for complete complete for leaflet information consumer enclosed the read product this using before Warnings

Directions

relieves external itching and irritation due to a vaginal yeast infection yeast vaginal a to due irritation and itching external relieves

Center right away. right Center

treats vaginal yeast infections infections yeast vaginal treats

If swallowed, get medical help or contact a Poison Control Control Poison a contact or help medical get swallowed, If children. of reach of out Keep Uses

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

Miconazole nitrate 2% (external cream)...... Vaginal antifungal cream)...... Vaginal (external 2% nitrate Miconazole

foul-smelling vaginal discharge vaginal foul-smelling

Miconazole nitrate 1200 mg (in vaginal insert)...... Vaginal antifungal insert)...... Vaginal vaginal (in mg 1200 nitrate Miconazole

you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or or vomiting, nausea, chills, fever, pain, abdominal hives, or rash a get you

Active ingredients Purpose ingredients Active

days 7 than more last symptoms days 3 in better get not do symptoms

Stop use and ask a doctor if doctor a ask and use Stop

Drug Facts Drug

) continued (

1 - DAY TREATMENT CURES MOST VAGINAL YEAST INFECTIONS YEAST VAGINAL MOST CURES TREATMENT DAY - 1

VAGINAL ANTIFUNGAL VAGINAL

Miconazole Nitrate Cream (2%) Cream Nitrate Miconazole (1200mg) Insert Vaginal Nitrate Miconazole

and COMBINATION PACK COMBINATION

ONE TREATMENT OVULE® Insert plus External Cream for Itch Relief

COMBINATION PACK Miconazole Nitrate Vaginal Insert (1200mg) and Miconazole Nitrate Cream (2%)

VAGINAL ANTIFUNGAL ? If you have any questions or comments, please call 1-877-MONISTAT (1-877-666-4782) or visit our website at www.monistat.com

NDC 62341-5411-0 Miconazole Nitrate Vaginal Insert (1200mg) Miconazole COMBINATION PACK

AND EXPIRATION DATE COMBINATION PACK LOCATION OF LOT# VAGINAL ANTIFUNGAL

and Miconazole Nitrate Cream (2%) Miconazole Nitrate Vaginal Insert (1200mg) Miconazole Nitrate Cream (2%) and and Miconazole Nitrate Cream (2%) Miconazole VAGINAL ANTIFUNGAL VAGINAL LY VAGINAL ANTIFUNGAL AL PR C O PACK COMBINATION I Miconazole Insert (1200mg) Nitrate Vaginal V N CURES MOST VAGINAL YEAST INFECTIONS AND I ORTHO E

L N RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

• • ORTHO 1 OVULE® Insert with Applicator Net Wt. 1 OVULE® Insert

plusplus External Cream +

0.32 oz. (9g) Tube

or visit our website at www.monistat.com at website our visit or 1-877-666-4782 1-877-MONISTAT call please comments, or questions any have you If 0 00 5411- 8004- 3 ) (

VAGINAL ANTIFUNGAL VAGINAL

INCOMPLETELY SEALED INCOMPLETELY Covered under patent number 5,514,698 number patent under Covered

718605 IS TORN, OPEN OR OPEN TORN, IS

Miconazole Nitrate Cream (2%) Cream Nitrate Miconazole (1200mg) Insert Vaginal Nitrate Miconazole

FPO and and

702-30-401-2 VAGINAL INSERT BLISTER BLISTER INSERT VAGINAL

MADE IN U.S.A. ©McNeil-PPC, Inc. 2003 Inc. ©McNeil-PPC, U.S.A. IN MADE

COMBINATION PACK COMBINATION

SEALED POUCH OR SEALED SEALED OR POUCH SEALED

Division of McNeil-PPC, Inc., Skillman, NJ 08558 08558 NJ Skillman, Inc., McNeil-PPC, of Division

PRINTED IF USE NOT DO

Personal Products Company Products Personal

TAMPER EVIDENT UNIT EVIDENT TAMPER Distributed by: Distributed

FDA STANDARD SIZES for Drug Facts Brand - Monistat File name - XXXXXX_M1Day_Night Design Agency Reference - AGT•seven

Category - Vaginal Anti Fungal Dieline No. - 33738R7 Project Name - Cooling Updates 12 point Helvetica Bold Italic Title Product Variant - Combo Pack Barcode No. - XXXXXX Artwork program - Ill. 10 10 point Helvetica Bold Italic Title (2nd column) Component Type - XXXXXX AGT•seven Job No. - 60694/2314 Lead Mktg. Country - USA 8 point Helvetica Bold Italic Headings Consumer Unit Contents - 1 Formulation No. - n/a Sales Region - North America 8 point Helvetica Condensed Med "Continued" Copy & Graphics Number- XXXXXX Printer - PCI Services Manufacturing Site - PSGA 6 point Helvetica Bold Subheads Version# - XXXXXX/1 No. of Colours - 6 Library - Local Market Artwork 6 point Helvetica Regular Text Date - 8/17/04 Print Method - Offset Keywords (Market) - XXXXXX, PC XXXX 6.5 point Leading

Colors: 6Note: All colors for reference only, printer to use pre-approved color Fonts: Helvetica,Trade Gothic JOHNSON & JOHNSON drawdowns when printing. Minion Bold, Helvetica Bold 2.5 point box hairline 199 Grandview Road Helvetica Condensed Bold Skillman, NJ 08558-9418 Zapf Humanist 601 BT Demi 2.5 point hairline 908-874-1666 (Consumer Graphics Dept. Fax) Helvetica 53 Extended Frutiger 65 Bold, OCR-B 0.5 point hairline • This proof indicates approximate color only! Arial Black, ITC Zapf Dingbats • All colors print 100% unless otherwise indicated. Monistat Dark PANTONE® PANTONE® Didot n • All structure and holding lines do not print unless Blue 226 109 5 point ITC Zapf Dingbats Bullet otherwise indicated. • This is prepared as a color digital mechanical, no traps have been made. • All trapping is the responsibility of the engraver and/or Consumer separator and/or printer. Graphics Manager: Bryan Petersen PANTONE® PANTONE® MATCH Phone: 908-874-2992 Cool Grey

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PANTONE® is a registered trademark of Pantone, Inc. try to create with All information contained herein is the CONFIDENTIAL property of Johnson & Johnson and may not be duplicated or released without the expressed written permission of Johnson & Johnson. (109 / 100%) – (Cool Grey 18%) – (226 / 8%) XXXXXX M1NonPrefillComboInser 8/17/04 4:03 PM Page 1

Consumer Information Leaflet 624-10-403-3 /”HEIGHT 1/2” BAR CODE 6-DIGIT

COMBINATION PACK Miconazole Nitrate Vaginal Insert (1200mg) and Miconazole Nitrate Cream (2%)

VAGINAL ANTIFUNGAL Cures Most Vaginal Yeast Infections and Relieves Associated External Itching and Irritation

Why should I use MONISTAT® 1 Combination Pack? Note: Vaginal yeast infections do NOT cause fever, chills, If you get vaginal yeast infections often (such as once a month lower abdominal, back or shoulder pain, foul-smelling vaginal MONISTAT® 1 Combination Pack contains a 1-dose OVULE® or 3 in 6 months), you should talk to a doctor. discharge, or a missed period. These may be signs of a sexu- Are vaginal yeast infections sexually transmitted? Insert that cures most vaginal yeast infections, plus an external ally transmitted disease (STD) or a tubal pregnancy. If you have cream that can be used for relief of itching and irritation on the skin these symptoms, call your doctor right away. Vaginal yeast infections are usually not spread by having inter- outside the vagina (vulva) due to a yeast infection. Do not use course (sex). However, if your partner has a rash, itching or dis- ® MONISTAT 1 Combination Pack if this is the first time you have What are other causes of a vaginal discharge? comfort in his genital area, he should contact a doctor to find out vaginal discharge, itching, burning and discomfort. See your It is normal to have a small amount of vaginal discharge at cer- the cause of his symptoms and tell the doctor that you are treating doctor or health professional first to find out the cause of your tain times of the month. This normal discharge may be clear or your vaginal yeast infection with MONISTAT® 1 Combination Pack. symptoms. If a doctor has told you in the past that you had a slightly white and does not cause itching, pain or a foul odor. vaginal yeast infection and you have the same symptoms now (such The most common cause of an abnormal vaginal discharge is an How can I prevent repeated vaginal yeast infections? as vaginal discharge, itching or burning), then MONISTAT® 1 Combination infection. These infections include bacterial vaginosis (BV), tri- To lower your chances of getting another yeast infection: Pack may work for you. chomoniasis (Trich), gonorrhea (GC) and/or chlamydia. All of these • Try to keep the genital area cool and dry. Yeast grow well in What is a vaginal yeast infection? may be transmitted sexually and are called sexually transmitted warm, moist areas. The following suggestions may be helpful: diseases (STDs). If you have more questions about sexually trans- (1) Wear cotton underwear and loose-fitting clothes. A vaginal yeast infection is a common condition caused by an mitted diseases (STDs) call the CDC STD Hotline at 1-800-227-8922. overgrowth of yeast (Candida) that may normally live in the vagina. (2) Change out of damp clothes or a wet bathing suit as soon as possible. Your doctor may call this infection "monilia" or "candidiasis." Some Although many of the infections mentioned above can cause symptoms similar to a vaginal yeast infection (vaginal discharge, irritation and (3) If you use minipads when you are not having a menstrual period, women may have a yeast infection on the skin outside of the vagina itching), their diagnosis must be made by a doctor so that proper (vulva) at the same time that they have a vaginal infection. change the minipads often. treatment can be given. • Talk with your doctor about any drugs you are now taking. You Who can get a vaginal yeast infection? If these infections are not properly treated or if proper treatment is are more likely to get a vaginal yeast infection if you are taking You can get a vaginal yeast infection at any age. It is most delayed, serious problems, such as pelvic inflammatory disease (PID) certain drugs such as antibiotics, steroids, or birth control pills. Do common during the childbearing years. Women who are pregnant or may result, which may prevent you from having children in the future. If not stop taking these drugs without first asking your doctor. A diabetic, taking antibiotics, birth control pills or steroids, or who you are pregnant and do not get the proper treatment, the infection may doctor may need to see you to make sure that you do not have have a weakened immune system are more likely to get repeated be passed to your baby before or during delivery and may cause your other medical conditions such as diabetes or a weakened immune yeast infections that may not clear up easily with proper treatment. baby to have permanent damage. If you have multiple sex partners or a system. new sex partner, you should also ask a doctor before use to make sure Some medical conditions can weaken the body’s normal ability ® you do not have an STD. Can I use MONISTAT 1 Combination Pack during my menstrual to fight infection. One of the most serious of these conditions is period? infection with the human immunodeficiency virus (HIV – the virus Why do women get repeated vaginal yeast infections? Yes, this product can be used during your menstrual period. that causes AIDS). The HIV virus causes the body to be more likely Women may get repeated vaginal yeast infections that may not In fact, many women get vaginal yeast infections just before their to get infections, including vaginal yeast infections that may not ® clear up easily with proper treatment. Listed below are some of the period because of hormonal changes. Using MONISTAT 1 clear up easily with proper treatment. If you may have been ex- causes of repeated yeast infections: Combination Pack during your period will not affect how well this posed to HIV and get repeated vaginal yeast infections, you should • hormonal changes occurring a few days before the monthly product works. If you have started treatment and your period see your doctor right away. For more information on HIV infection, period occurs, you should complete the full course of treatment. please contact your doctor or the CDC National AIDS HOTLINE. • use of antibiotics The CDC phone numbers are: 1-800-342-AIDS (English), 1-800- Do not use tampons while using this product, because tampons • use of some birth control pills 344-7432 (Spanish), or 1-800-243-7889 (hearing impaired, TDD). may remove some of the drug from the vagina. Use deodorant-free • pregnancy sanitary napkins or pads instead, and change them often. How can I tell if I have a vaginal yeast infection? • diabetes ("sugar" or "high blood sugar") When you have a vaginal yeast infection, you may have one or Can I use other vaginal products with MONISTAT® 1 more of the following symptoms: • clothing – wearing tight layers or moist clothing in the genital area Combination Pack? • vaginal itching • weakened immune system – some drugs (such as chemother- This drug should not be used with other vaginal products. • vaginal discharge that may be thick, white, and lumpy like apy or steroids) and medical conditions can weaken the body’s ® cottage cheese normal ability to fight infection. One of the most serious of these • Douches and tampons may remove some of the OVULE Insert • vaginal soreness, irritation, or burning conditions is infection with the human immunodeficiency virus from the vagina. • rash or redness on the skin outside the vagina (vulva) (HIV – the virus that causes AIDS). Infection with HIV causes the • Spermicides may interfere with MONISTAT® 1 Combination Pack. • burning on urination person to be more likely to get infections, including vaginal yeast • Condoms and diaphragms may be damaged by this product and • painful vaginal intercourse (sex) infections. fail to prevent pregnancy or sexually transmitted diseases (STDs).

Brand - Monistat File name - Mon1 non prefilled ComboInsert Design Agency Reference - SEVEN

Category - Vaginal Antifungal Dieline No. - n/a Project Name - Daytime

Product Variant - non-Prefilled (Ovual Insert) Combination Barcode No. (+ BWR & Mag) - n/a Artwork program - Illustrator 8.0

Component Type - Insert Seven Job No. - 6069/2314 Lead Mktg. Country - USA

Consumer Unit Contents - Formulation No. - n/a Sales Region - North America

Copy & Graphics Number - XXXXXX Printer - PCI Triline Manufacturing Site - PSGA

Version# - 2 No. of Colours - 2 Library - Local Market Artwork

Date - 8/17/04 Print Method - offset Keywords (Market) - XXXXXX

Colors: 2 Fonts: Note: All colors for reference only, printer to use pre-approved color Optima / MathPi / Helv. Condensed drawdowns when printing. Johnson & Johnson Helv. Neue / Helv. Neue Condensed 199 Grandview Road Helv. Neue Extended, Helv. Condensed- Skillman, NJ 08558-9418 Italic, Helv. Roman 908-874-1666 (Consumer Graphics Dept. Fax) PANTONE¤ PANTONE¤ ¥ This proof indicates approximate color only! 300 Cl Gy 10 ¥ All colors print 100% unless otherwise indicated. ¥ All structure and holding lines do not print unless otherwise indicated. ¥ This is prepared as a color digital mechanical, Consumer no traps have been made. Graphics Manager: Bridgette Motley ¥ All trapping is the responsibility of the engraver and/or separator and/or printer. ARTWORK SPECIFICS Phone: 908.874.2736

PANTONE® is a registered trademark of Pantone, Inc. All information contained herein is the CONFIDENTIAL property of Johnson & Johnson and may not be duplicated or released without the expressed written permission of Johnson & Johnson. XXXXXX M1NonPrefillComboInser 8/17/04 4:03 PM Page 2

How can I get the best results when treating my infection? How Should I Use MONISTAT® 1 Directions for using the External Vulvar Cream • Use the OVULE® Insert, even during your menstrual period. Use the cream twice daily, for up to 7 days as needed. • Use the tube of cream externally only while symptoms are pre- Combination Pack ? 1. Open the tube by unscrewing the cap. The first time the sent. If you have symptoms (such as itching and irritation) on the This product is for adults and children 12 years of age tube is opened, press the sharp point of the cap into the skin outside the vagina (vulva), apply the cream externally 2 times and over. For children under 12 years, ask a doctor. sealed end of the tube. Push a day, up to a total of 7 days, as needed. down firmly until the seal is open. • Dry the genital area thoroughly after a shower, bath or swim. Directions for using the Applicator and 2. Squeeze a small amount of Change out of a wet bathing suit or damp clothes as soon as the OVULE® Insert : (tear at notch) cream onto your fingertip. possible. A dry area is less likely to lead to the overgrowth of 3. Apply the cream onto the yeast. 1 Open pouch and remove contents. skin outside the vagina (vulva) (see picture). • Wear cotton underwear and loose-fitting clothes. that itches and is irritated. KEEP CONTENTS DRY BEFORE USE. . Screw the cap back on the tube. • Wipe from front to back after a bowel movement or after urination. 4 5. Repeat steps 2 – 4, up to two times daily, • Do not douche, because douching may wash the drug out of the as needed. vagina. Separate the • Do not use tampons, because they remove some of the drug from 2 Stop use and ask your doctor if: paper backing from the vagina. Use deodorant-free sanitary napkins or pads as • symptoms do not get better in 3 days needed. blister pack by peeling back the • symptoms last more than 7 days • Do not use spermicides, as they may interfere with MONISTAT® 1 cover from the PAPER BACKING • you get a rash or hives, abdominal pain, fever, chills, nausea, Combination Pack. corner. (see picture). vomiting, or foul-smelling vaginal discharge. ® • Do not have vaginal intercourse while using MONISTAT 1 ® OVULE These may be signs that this product is not working, or you may have a Combination Pack. INSERT more serious condition or an allergic reaction. ® • Do not scratch the skin outside the vagina. Scratching can cause 3 Place the OVULE Insert firmly into If pregnant or breast-feeding, ask a health professional before use. more irritation and can spread the infection. the top (wider end) of the applicator so it APPLICATOR will not fall out. BARREL Keep out of reach of children. If swallowed, get medical help or • Tell your doctor about any drugs you are now taking. Certain contact a Poison Control Center right away. drugs such as antibiotics, steroids, and birth control pills, may What side effects may occur with MONISTAT® 1 Combination make it more likely for you to get a vaginal yeast infection. If you 4 Hold the Applicator containing Pack? are taking any of these drugs do not stop taking them without first ® PLUNGER A mild increase in vaginal burning, itching, or irritation may occur the OVULE Insert by the opposite ® asking a doctor. ® when the OVULE Insert is inserted. Abdominal cramping has also end from where the OVULE Insert been reported. • If you have any other medical questions or concerns about is located. vaginal yeast infections, call your doctor. Stop using MONISTAT®1 Combination Pack and consult your doctor What warnings should I know about when using MONISTAT® 1 if you have abdominal pain, hives, skin rash, or if you have severe Combination Pack? Gently insert the appl- vaginal burning, itching, or irritation or swelling. 5 ® For vaginal use only. icator into the vagina as far What should I do if I have questions about MONISTAT 1 Do not use if you have never had a vaginal yeast infection as it will go comfortably. Combination Pack? diagnosed by a doctor. This can be done while Questions of a medical nature should be taken up with your doctor. Ask a doctor before use if you have: standing with your feet UTERUS If you have any other questions or need more information on this product, call our toll-free number. Call between 8:00 AM and 5:00 PM • vaginal itching and discomfort for the first time. You may need spread a few inches apart URINARY Eastern time, Monday through Friday. A health care specialist will a different treatment. and your knees bent. Or, OPENING you can lie on your back VAGINA CERVIX gladly answer your questions. Our toll-free number is 1-877-MONISTAT • lower abdominal, back or shoulder pain, fever, chills, nausea, with your knees bent, as (1-877-666-4782). vomiting, or foul-smelling vaginal discharge. You could have shown in the picture. RECTUM a more serious condition. Other Information: • TAMPER-EVIDENT UNIT – do not use if printed sealed pouch or • vaginal yeast infections often (such as once a month or 3 in 6 sealed vaginal insert blister is torn, open or incompletely sealed. months). You could be pregnant or have a serious underlying 6 With one hand holding the barrel, use the other hand • do not use if tube seal has been punctured or embossed design medical cause for your symptoms, including diabetes or a weak- to push the plunger all the way in to place the OVULE® ened immune system. symbol is not visible. Insert as far back in the vagina as possible. Then re- • store at 20° – 25° C (68° – 77° F) • been exposed to the human immunodeficiency virus (HIV) that move both parts of the applicator from the vagina. causes AIDS. • this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in Ask a doctor or pharmacist before use if you are taking the prescrip- 7 Throw away applicator after use. Do not flush in toilet. 1 day and complete relief by 7 days. tion blood thinning medicine, warfarin (coumadin), because ® bleeding or bruising may occur. Active ingredients: OVULE Insert: miconazole nitrate, 1200 mg. When using this product: External Vulvar Cream – miconazole nitrate, 2%. • do not use tampons, douches, spermicides, or other You may want to use deodorant-free pads or pantyshields Inactive ingredients: OVULE® Insert: gelatin, glycerin, lecithin, mineral vaginal products. Condoms and diaphragms may be to protect your clothing during the time that you are using oil, titanium dioxide, white petrolatum. External Vulvar Cream: benzoic damaged and fail to prevent pregnancy or sexually MONISTAT® 1 Combination Pack. This is because the acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium transmitted diseases (STDs). OVULE® Insert can leak or you may get some discharge. hydroxide, propylene glycol, purified water, stearyl alcohol. • do not have vaginal intercourse Do not use tampons, douches, spermicides, condoms Distributed by: 6-DIGIT or diaphragms until after you have completed the treat- Personal Products Company BAR CODE • mild increase in vaginal burning, itching or irritation 1/2” HEIGHT may occur ment and your symptoms are gone. Division of McNeil-PPC, Inc. Skillman, NJ 08558 ©McNeil-PPC, Inc. 2003 XXXXXX 624-10-403-3

Questions? Questions?

do not have vaginal intercourse intercourse vaginal have not do

hydroxide, propylene glycol, purified water, stearyl alcohol stearyl water, purified glycol, propylene hydroxide, diseases (STDs). diseases

gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum white dioxide, titanium oil, mineral lecithin, glycerin, gelatin, insert: vaginal

do not use tampons, douches, spermicides or other vaginal products. Condoms and and Condoms products. vaginal other or spermicides douches, tampons, use not do

Inactive ingredients Inactive

When using this product this using When

1 day. Most women get some improvement in 1 day and complete relief by 7 days. 7 by relief complete and day 1 in improvement some get women Most day. 1

medicine warfarin, because bleeding or bruising may occur may bruising or bleeding because warfarin, medicine

this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just in symptoms their of relief complete get not do women Most treatment. 1-dose a is this

taking the prescription blood thinning blood prescription the taking are you if use before pharmacist or doctor a Ask

F) F) -77 (68 C -25 20 at store ° ° ° °

do not purchase if carton is open open is carton if purchase not do

do not use if seal over tube opening has been punctured or embossed design is not visible not is design embossed or punctured been has opening tube over seal if use not do

been exposed to the human immunodeficiency virus (HIV) that causes AIDS causes that (HIV) virus immunodeficiency human the to exposed been

sealed pouch is torn, open or incompletely sealed sealed incompletely or open torn, is pouch sealed printed if use not do or a weakened immune system. immune weakened a or

Other information information Other

pregnant or have a serious underlying medical cause for your symptoms, including diabetes diabetes including symptoms, your for cause medical underlying serious a have or pregnant

vaginal yeast infections often (such as once a month or 3 in 6 months). You could be be could You months). 6 in 3 or month a once as (such often infections yeast vaginal

children under 12 years of age: ask a doctor a ask age: of years 12 under children

vaginal discharge. You may have a more serious condition. serious more a have may You discharge. vaginal days, as needed. as days,

time first the for discomfort and itching vaginal

squeeze a small amount of cream onto your fingertip. Apply the the Apply fingertip. your onto cream of amount small a squeeze cream: external

Ask a doctor before use if you have you if use before doctor a Ask Throw applicator away after use. after away applicator Throw

with the applicator place the vaginal insert into the vagina. vagina. the into insert vaginal the place applicator the with insert: vaginal

if you have never had a vaginal yeast infection diagnosed by a doctor a by diagnosed infection yeast vaginal a had never have you if use not Do

adults and children 12 years of age and over: and age of years 12 children and adults

For vaginal use only use vaginal For directions and information and directions

before using this product read the enclosed consumer information leaflet for complete complete for leaflet information consumer enclosed the read product this using before Warnings

Directions

relieves external itching and irritation due to a vaginal yeast infection yeast vaginal a to due irritation and itching external relieves

Center right away. right Center

treats vaginal yeast infections infections yeast vaginal treats

If swallowed, get medical help or contact a Poison Control Control Poison a contact or help medical get swallowed, If children. of reach of out Keep Uses

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

Miconazole nitrate 2% (external cream)...... Vaginal antifungal cream)...... Vaginal (external 2% nitrate Miconazole

foul-smelling vaginal discharge vaginal foul-smelling

Miconazole nitrate 1200 mg (in vaginal insert)...... Vaginal antifungal insert)...... Vaginal vaginal (in mg 1200 nitrate Miconazole

you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or or vomiting, nausea, chills, fever, pain, abdominal hives, or rash a get you

Active ingredients Purpose ingredients Active

days 7 than more last symptoms days 3 in better get not do symptoms

Stop use and ask a doctor if doctor a ask and use Stop

Drug Facts Drug

) continued (

1 - DAY TREATMENT CURES MOST VAGINAL YEAST INFECTIONS YEAST VAGINAL MOST CURES TREATMENT DAY - 1

VAGINAL ANTIFUNGAL VAGINAL

Miconazole Nitrate Cream (2%) Cream Nitrate Miconazole (1200mg) Insert Vaginal Nitrate Miconazole

and COMBINATION PACK COMBINATION

ONE TREATMENT OVULE® Insert Prefilled Applicator plus External Cream for Itch Relief

COMBINATION PACK Miconazole Nitrate Vaginal Insert (1200mg) and Miconazole Nitrate Cream (2%)

VAGINAL ANTIFUNGAL ? If you have any questions or comments, please call 1-877-MONISTAT (1-877-666-4782) or visit our website at www.monistat.com NDC 62341-5411-2 CONVENIENT PREFILLED APPLICATOR Miconazole Nitrate Vaginal Insert (1200mg) Miconazole COMBINATION PACK AND EXPIRATION DATE LOCATION OF LOT# VAGINAL ANTIFUNGAL COMBINATION PACK Miconazole Nitrate Cream (2%) and and and Miconazole Nitrate Vaginal Insert (1200mg) Miconazole Nitrate Cream (2%) Miconazole Nitrate Cream (2%) Miconazole VAGINAL ANTIFUNGAL VAGINAL LY AL PR C O PACK COMBINATION I VAGINAL ANTIFUNGAL Miconazole Insert (1200mg) Nitrate Vaginal V N I ORTHO E

L N CURES MOST VAGINAL YEAST INFECTIONS AND

• RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION • ORTHO 1 OVULE® Insert Prefilled Applicator Net Wt. 1 OVULE® Insert

plusplus External Cream +

0.32 oz. (9g) Tube

8004-5411-00

0 3

or visit our website at www.monistat.com at website our visit or 1-877-666-4782 1-877-MONISTAT call please comments, or questions any have you If ) (

VAGINAL ANTIFUNGAL VAGINAL

SEALED

Covered under patent number 5,514,698 number patent under Covered

OR INCOMPLETELY INCOMPLETELY OR

718605

Miconazole Nitrate Cream (2%) Cream Nitrate Miconazole (1200mg) Insert Vaginal Nitrate Miconazole

FPO and and

702-30-401-2 POUCH IS TORN, OPEN TORN, IS POUCH

Division of McNeil-PPC, Inc., Skillman, NJ 08558 08558 NJ Skillman, Inc., McNeil-PPC, of Division DO NOT USE IF USE NOT DO

Personal Products Company Products Personal

TAMPER EVIDENT UNIT EVIDENT TAMPER Distributed by: Distributed

FDA STANDARD SIZES for Drug Facts Brand - Monistat File name - XXXXXX_M1Combo_prefill Design Agency Reference - AGT•seven

ARTWORK SPECIFICS Purple GOLD 10 Manufactured Gold is needed for rules

Consumer Information Leaflet 624-10-403-3 /”HEIGHT 1/2” BAR CODE 6-DIGIT

COMBINATION PACK Miconazole Nitrate Vaginal Insert (1200mg) and Miconazole Nitrate Cream (2%)

VAGINAL ANTIFUNGAL Cures Most Vaginal Yeast Infections and Relieves Associated External Itching and Irritation

Why should I use MONISTAT® 1 Combination Pack with Prefilled Note: Vaginal yeast infections do NOT cause fever, chills, Are vaginal yeast infections sexually transmitted? Applicator? lower abdominal, back or shoulder pain, foul-smelling vaginal Vaginal yeast infections are usually not spread by having inter- discharge, or a missed period. These may be signs of a sexu- MONISTAT® 1 Combination Pack with Prefilled Applicator con- course (sex). However, if your partner has a rash, itching or dis- ally transmitted disease (STD) or a tubal pregnancy. If you have tains a 1-dose OVULE® Insert that cures most vaginal yeast infec- comfort in his genital area, he should contact a doctor to find out these symptoms, call your doctor right away. tions, plus an external cream that can be used for relief of itching the cause of his symptoms and tell the doctor that you are treating and irritation on the skin outside the vagina (vulva) due to a yeast What are other causes of a vaginal discharge? your vaginal yeast infection with MONISTAT® 1 Combination Pack ® infection. Do not use MONISTAT 1 Combination Pack with It is normal to have a small amount of vaginal discharge at cer- with Prefilled Applicator. Prefilled Applicator if this is the first time you have vaginal tain times of the month. This normal discharge may be clear or How can I prevent repeated vaginal yeast infections? discharge, itching, burning and discomfort. See your doctor or slightly white and does not cause itching, pain or a foul odor. To lower your chances of getting another yeast infection: health professional first to find out the cause of your symptoms. The most common cause of an abnormal vaginal discharge is an • Try to keep the genital area cool and dry. Yeast grow well in If a doctor has told you in the past that you had a vaginal yeast infection. These infections include bacterial vaginosis (BV), tri- infection and you have the same symptoms now (such as vaginal warm, moist areas. The following suggestions may be helpful: ® chomoniasis (Trich), gonorrhea (GC) and/or chlamydia. All of these discharge, itching or burning), then MONISTAT 1 Combination Pack may be transmitted sexually and are called sexually transmitted (1) Wear cotton underwear and loose-fitting clothes. with Prefilled Applicator may work for you. diseases (STDs). If you have more questions about sexually trans- (2) Change out of damp clothes or a wet bathing suit as soon as possible. What is a vaginal yeast infection? mitted diseases (STDs) call the CDC STD Hotline at 1-800-227-8922. (3) If you use minipads when you are not having a menstrual period, A vaginal yeast infection is a common condition caused by an Although many of the infections mentioned above can cause symp- change the minipads often. overgrowth of yeast (Candida) that may normally live in the vagina. toms similar to a vaginal yeast infection (vaginal discharge, irritation and Your doctor may call this infection "monilia" or "candidiasis." Some itching), their diagnosis must be made by a doctor so that proper • Talk with your doctor about any drugs you are now taking. You women may have a yeast infection on the skin outside of the vagina treatment can be given. are more likely to get a vaginal yeast infection if you are taking (vulva) at the same time that they have a vaginal infection. certain drugs such as antibiotics, steroids, or birth control pills. Do If these infections are not properly treated or if proper treatment is not stop taking these drugs without first asking your doctor. A Who can get a vaginal yeast infection? delayed, serious problems, such as pelvic inflammatory disease (PID) doctor may need to see you to make sure that you do not have You can get a vaginal yeast infection at any age. It is most may result, which may prevent you from having children in the future. If other medical conditions such as diabetes or a weakened immune common during the childbearing years. Women who are pregnant or you are pregnant and do not get the proper treatment, the infection may system. be passed to your baby before or during delivery and may cause your diabetic, taking antibiotics, birth control pills or steroids, or who ® have a weakened immune system are more likely to get repeated baby to have permanent damage. If you have multiple sex partners or a Can I use MONISTAT 1 Combination Pack with Prefilled yeast infections that may not clear up easily with proper treatment. new sex partner, you should also ask a doctor before use to make sure Applicator during my menstrual period? Some medical conditions can weaken the body’s normal ability you do not have an STD. Yes, this product can be used during your menstrual period. to fight infection. One of the most serious of these conditions is Why do women get repeated vaginal yeast infections? In fact, many women get vaginal yeast infections just before their period because of hormonal changes. Using MONISTAT® 1 infection with the human immunodeficiency virus (HIV – the virus Women may get repeated vaginal yeast infections that may not that causes AIDS). The HIV virus causes the body to be more likely Combination Pack with Prefilled Applicator during your period will clear up easily with proper treatment. Listed below are some of the not affect how well this product works. If you have started treat- to get infections, including vaginal yeast infections that may not causes of repeated yeast infections: clear up easily with proper treatment. If you may have been ex- ment and your period occurs, you should complete the full course • hormonal changes occurring a few days before the monthly of treatment. posed to HIV and get repeated vaginal yeast infections, you should period see your doctor right away. For more information on HIV infection, Do not use tampons while using this product, because tampons • use of antibiotics please contact your doctor or the CDC National AIDS HOTLINE. may remove some of the drug from the vagina. Use deodorant-free The CDC phone numbers are: 1-800-342-AIDS (English), 1-800- • use of some birth control pills sanitary napkins or pads instead, and change them often. • pregnancy 344-7432 (Spanish), or 1-800-243-7889 (hearing impaired, TDD). ® • diabetes ("sugar" or "high blood sugar") Can I use other vaginal products with MONISTAT 1 How can I tell if I have a vaginal yeast infection? Combination Pack with Prefilled Applicator? When you have a vaginal yeast infection, you may have one or • clothing – wearing tight layers or moist clothing in the genital area • weakened immune system – some drugs (such as chemother- This drug should not be used with other vaginal products. more of the following symptoms: ® • vaginal itching apy or steroids) and medical conditions can weaken the body’s • Douches and tampons may remove some of the OVULE Insert normal ability to fight infection. One of the most serious of these from the vagina. • vaginal discharge that may be thick, white, and lumpy like conditions is infection with the human immunodeficiency virus • Spermicides may interfere with MONISTAT® 1 Combination Pack cottage cheese (HIV – the virus that causes AIDS). Infection with HIV causes the • vaginal soreness, irritation, or burning person to be more likely to get infections, including vaginal yeast with Prefilled Applicator. • rash or redness on the skin outside the vagina (vulva) infections. • Condoms and diaphragms may be damaged by this product and • burning on urination If you get vaginal yeast infections often (such as once a month fail to prevent pregnancy or sexually transmitted diseases (STDs). • painful vaginal intercourse (sex) or 3 in 6 months), you should talk to a doctor.

Brand - Monistat File name - Mon1ComboInsert Design Agency Reference - SEVEN

Category - Vaginal Antifungal Dieline No. - n/a Project Name - Daytime

Product Variant - Prefilled (Ovual Insert) Combination Barcode No. (+ BWR & Mag) - n/a Artwork program - Illustrator 8.0

Component Type - Insert Seven Job No. - 6069/2314 Lead Mktg. Country - USA

Consumer Unit Contents - Formulation No. - n/a Sales Region - North America

Copy & Graphics Number - XXXXXX Printer - PCI Triline Manufacturing Site - PSGA

Version# - 2 No. of Colours - 2 Library - Local Market Artwork

Date - 8/17/04 Print Method - offset Keywords (Market) - XXXXXX

Colors: 2 Fonts: Note: All colors for reference only, printer to use pre-approved color Optima / MathPi / Helv. Condensed drawdowns when printing. Johnson & Johnson Helv. Neue / Helv. Neue Condensed 199 Grandview Road Helv. Neue Extended, Helv. Condensed- Skillman, NJ 08558-9418 Italic, Helv. Roman 908-874-1666 (Consumer Graphics Dept. Fax) PANTONE¨ PANTONE¨ ¥ This proof indicates approximate color only! 300 Cl Gy 10 ¥ All colors print 100% unless otherwise indicated. ¥ All structure and holding lines do not print unless otherwise indicated. ¥ This is prepared as a color digital mechanical, Consumer no traps have been made. Graphics Manager: Bridgette Motley ¥ All trapping is the responsibility of the engraver and/or separator and/or printer. ARTWORK SPECIFICS Phone: 908.874.2736

How can I get the best results when treating my infection? ® Directions for using the External Vulvar Cream ® How Should I Use MONISTAT 1 • Use the Applicator containing the OVULE Insert, even during Use the cream twice daily, for up to 7 days as needed. your menstrual period. Combination Pack with Prefilled 1. Open the tube by unscrewing the cap. The first time the • Use the tube of cream externally only while symptoms are pre- Applicator? tube is opened, press the sharp point of the cap into the sent. If you have symptoms (such as itching and irritation) on the sealed end of the tube. Push skin outside the vagina (vulva), apply the cream externally 2 times This product is for adults and children 12 years of age a day, up to a total of 7 days, as needed. and over. For children under 12 years, ask a doctor. down firmly until the seal is open. 2. Squeeze a small amount of • Dry the genital area thoroughly after a shower, bath or swim. Directions for using the Applicator containing cream onto your fingertip. Change out of a wet bathing suit or damp clothes as soon as 3. Apply the cream onto the possible. A dry area is less likely to lead to the overgrowth of the OVULE® Insert : yeast. skin outside the vagina (vulva) that itches and is irritated. • Wear cotton underwear and loose-fitting clothes. 4. Screw the cap back on the tube. • Wipe from front to back after a bowel movement or after urination. 1 Open pouch and (tear at notch) 5. Repeat steps 2 – 4, up to two times daily, • Do not douche, because douching may wash the drug out of the remove Prefilled Applicator. as needed. vagina. (see picture). • Do not use tampons, because they remove some of the drug from Stop use and ask your doctor if: KEEP CONTENTS • symptoms do not get better in 3 days the vagina. Use deodorant-free sanitary napkins or pads as DRY BEFORE USE. needed. • symptoms last more than 7 days • Do not use spermicides, as they may interfere with MONISTAT® 1 • you get a rash or hives, abdominal pain, fever, chills, nausea, Combination Pack with Prefilled Applicator. vomiting, or foul-smelling vaginal discharge. • Do not have vaginal intercourse while using MONISTAT® 1 These may be signs that this product is not working, or you may have a Combination Pack with Prefilled Applicator. more serious condition or an allergic reaction. • Do not scratch the skin outside the vagina. Scratching can cause If pregnant or breast-feeding, ask a health professional before use. more irritation and can spread the infection. Keep out of reach of children. If swallowed, get medical help or • Tell your doctor about any drugs you are now taking. Certain contact a Poison Control Center right away. drugs such as antibiotics, steroids, and birth control pills, may 2 Hold the Applicator containing the OVULE® Insert What side effects may occur with MONISTAT® 1 Combination Pack make it more likely for you to get a vaginal yeast infection. If you by the opposite end from where the OVULE® Insert is with Prefilled Applicator? are taking any of these drugs do not stop taking them without first located. A mild increase in vaginal burning, itching, or irritation may occur asking a doctor. when the Applicator containing the OVULE® Insert is inserted. • If you have any other medical questions or concerns about Abdominal cramping has also been reported. vaginal yeast infections, call your doctor. 3 Gently insert the appl- Stop using MONISTAT®1 Combination Pack with Prefilled Applicator What warnings should I know about when using MONISTAT® 1 icator into the vagina as far and consult your doctor if you have abdominal pain, hives, skin rash, or Combination Pack with Prefilled Applicator? as it will go comfortably. if you have severe vaginal burning, itching, or irritation or swelling. This can be done while What should I do if I have questions about MONISTAT® 1 For vaginal use only. standing with your feet UTERUS Combination Pack with Prefilled Applicator?

Do not use if you have never had a vaginal yeast infection spread a few inches apart URINARY Questions of a medical nature should be taken up with your doctor. diagnosed by a doctor. and your knees bent. Or, OPENING If you have any other questions or need more information on this you can lie on your back Ask a doctor before use if you have: VAGINA CERVIX product, call our toll-free number. Call between 8:00 AM and 5:00 PM with your knees bent, as Eastern time, Monday through Friday. A health care specialist will • vaginal itching and discomfort for the first time. You may need shown in the picture. RECTUM gladly answer your questions. Our toll-free number is 1-877-MONISTAT a different treatment. (1-877-666-4782). • lower abdominal, back or shoulder pain, fever, chills, nausea, Other Information: vomiting, or foul-smelling vaginal discharge. You could have 4 With one hand holding the barrel, use the other hand a more serious condition. to push the plunger all the way in to place the OVULE® • TAMPER-EVIDENT UNIT – do not use if printed sealed pouch is torn, open or incompletely sealed. • vaginal yeast infections often (such as once a month or 3 in 6 Insert as far back in the vagina as possible. Then re- months). You could be pregnant or have a serious underlying move both parts of the applicator from the vagina. • do not use if tube seal has been punctured or embossed design medical cause for your symptoms, including diabetes or a weak- symbol is not visible. ened immune system. • store at 20° – 25° C (68° – 77° F) Throw away applicator after use. Do not flush in toilet. • been exposed to the human immunodeficiency virus (HIV) that 5 • this is a 1-dose treatment. Most women do not get complete relief of causes AIDS. their symptoms in just 1 day. Most women get some improvement in Ask a doctor or pharmacist before use if you are taking the prescrip- 1 day and complete relief by 7 days. You may want to use deodorant-free pads or pantyshields ® tion blood thinning medicine, warfarin (coumadin), because Active ingredients: OVULE Insert: miconazole nitrate, 1200 mg. to protect your clothing during the time that you are using bleeding or bruising may occur. ® External Vulvar Cream – miconazole nitrate, 2%. MONISTAT 1 Combination Pack with Prefilled Applicator. ® When using this product: ® Inactive ingredients: OVULE Insert: gelatin, glycerin, lecithin, mineral This is because the OVULE Insert can leak or you may oil, titanium dioxide, white petrolatum. External Vulvar Cream: benzoic • do not use tampons, douches, spermicides, or other get some discharge. Do not use tampons, douches, acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium vaginal products. Condoms and diaphragms may be spermicides, condoms or diaphragms until after you hydroxide, propylene glycol, purified water, stearyl alcohol. damaged and fail to prevent pregnancy or sexually have completed the treatment and your symptoms are transmitted diseases (STDs). gone. Distributed by: 6-DIGIT Personal Products Company BAR CODE • do not have vaginal intercourse 1/2” HEIGHT Division of McNeil-PPC, Inc. • mild increase in vaginal burning, itching or irritation Skillman, NJ 08558 624-10-403-3 may occur ©McNeil-PPC, Inc. 2003 XXXXXX