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

Home , Miconazole

Questions? Questions? If you have any questions or comments, please call 1-877-666-4782 call please comments, or questions any have you If

benzoic acid, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol stearyl water, purified glycol, propylene hydroxide, potassium 60, polysorbate myristate, isopropyl acid, benzoic cream: external

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

Inactive ingredients Inactive

F) F) -77 (68 C -25 20 at store 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 wrapped) individually is insert (vaginal damaged or missing is wrapper if use not do

Other information Other

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

times daily for up to 7 days, as needed. as days, 7 to up for daily times 2 Use vagina. the outside skin irritated itchy, the onto cream the Apply fingertip. your onto cream of amount small a squeeze cream: external

with the applicator place the vaginal insert into the vagina at bedtime. Throw applicator away after use. after away applicator Throw bedtime. at vagina the into insert vaginal the place applicator the with insert: vaginal

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

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

Directions

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

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

you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge vaginal foul-smelling or vomiting, nausea, chills, fever, pain, abdominal hives, or rash a get you

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

mild increase in vaginal burning, itching or irritation may occur may irritation or itching burning, vaginal in increase mild intercourse vaginal have not do

regnancy or sexually transmitted diseases (STDs). diseases transmitted sexually or regnancy p prevent to fail and damaged be may diaphragms and Condoms products. vaginal other or spermicides douches, tampons, use not do

When using this product this using When

bruising may occur may bruising or bleeding because warfarin, medicine thinning blood prescription the taking are you if use before pharmacist or doctor a Ask

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

or a weakened immune system. immune weakened a or

cal cause for your symptoms, including diabetes diabetes including symptoms, your for cause cal medi underlying serious a have or pregnant be could You months). 6 in 3 or month a once as (such often infections yeast vaginal

e serious condition. serious e mor a have may You discharge. vaginal foul-smelling or vomiting nausea, chills, fever, pain, shoulder or back abdominal, lower

time first the for discomfort and itching vaginal

Ask a doctor before use if you have you if use before doctor a Ask

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

For vaginal use only use vaginal For

Warnings

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

Uses

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

inal antifungal inal ...... Vag insert)...... vaginal each (in mg 1200 nitrate Miconazole

Purpose ingredients Active

Drug Facts Drug

VAGINAL ANTIFUNGAL VAGINAL

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

CURES MOST VAGINAL YEAST INFECTIONS YEAST VAGINAL MOST CURES

COMBINATION PACK COMBINATION 1 - DAY TREATMENT DAY - 1

NEW! 1 DAY with TREATMENT External Cream for Itch Relief Soft Gel Vaginal Insert with Applicator

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 Miconazole Nitrate Vaginal Insert (1200mg) Nitrate Vaginal Insert (1200mg) Miconazole COMBINATION PACK COMBINATION PACK VAGINAL ANTIFUNGAL

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

and and Miconazole Nitrate Cream (2%) Miconazole

VAGINAL ANTIFUNGAL ANTIFUNGAL VAGINAL COMBINATION PACK COMBINATION Miconazole Insert (1200mg) Nitrate Vaginal

CURES MOST VAGINAL YEAST INFECTIONS AND ORTHO RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION 1 Soft Gel Vaginal Insert With Applicator

plus External Cream Net Wt. 0.32 oz. Insert, (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 ) (

VAGINAL ANTIFUNGAL VAGINAL

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

OR BROKEN OR

000-00-000-0

Miconazole Nitrate Cream (2%) Cream Nitrate Miconazole and (1200mg) Insert Vaginal Nitrate Miconazole BEEN EITHER REMOVED EITHER BEEN

MADE IN U.S.A. ©McNeil-PPC, Inc. 2001 Inc. ©McNeil-PPC, U.S.A. IN MADE

DO NOT USE IF SEAL HAS SEAL IF USE NOT DO

COMBINATION PACK COMBINATION

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

WITH A PRINTED SEAL. PRINTED A WITH

Personal Products Company Products Personal

THIS CARTON IS SECURED IS CARTON THIS

Distributed by: Distributed PACKING TRAY INSIDE TRAY PACKING

Family of Companies

Brand - MONISTAT File name - Mon1ComboCtnND Design Agency Reference - Seven

Category - VAGINAL ANTIFUNGAL Dieline No. - 3626D Project Name Monistat 1 Combination Pack Manufactured Gold is needed for rules

Product Variant - COMBINATION PACK Barcode No. (+ BWR & Mag) Artwork program - Illustrator 8.0 try to create with 109 Ð Cool Grey 10 Ð 226 Component Type - OUTER CARTON Job No. - 33845/284 Lead Mktg. Country - USA

Consumer Unit Contents - Combo Formulation No. Sales Region - North America Copy & Graphics Number xxxxxx Printer - Manufacturing Site - n/a FDA STANDARD SIZES for Drug Facts GGM# / Version xxxxxxx /4 No. of Colours - 6+Varnish/0 Library Date 6/22/01 Print Method - offset Keywords (Market) 10 point Helvetica Bold Italic Title 8 point Helvetica Bold Italic Headings Colors: 5 + Varnish - front Fonts: AvantGarBoo HelveBolObl Note: All colors for reference only, printer to use pre-approved color AvantGarDem HelveConBol 6 point Helvetica Bold Subheads drawdowns when printing. AvantGarMed HelveConLig Family of Companies FrutiBla HelveNeuBolExt 6 point Helvetica Regular Text 199 Grandview Road FrutiBol HelveNeuCon Skillman, NJ 08558-9418 FrutiRom HelveNeuExt 908-874-1666 (Consumer Graphics Dept. Fax) Helve HelveNeuHeaConObl 6.5 point Leading HelveBol HelveNeuHeaExtObl PANTONE ¨ PANTONE ¨ PANTONE ¨ PANTONE ¨ PANTONE ¨ ¥ This proof indicates approximate color only! 109 226 288 Cool Grey 10 Purple HelveNeuMedExt ¥ All colors print 100% unless otherwise indicated. HelveNeuThiExt ¥ All structure and holding lines do not print unless ZapfDin 2.5 point box hairline otherwise indicated. ¥ This is prepared as a color digital mechanical, Consumer no traps have been made. VARNISH Graphics Manager: Bridgette Motley 2.5 point hairline ¥ All trapping is the responsibility of the engraver ARTWORK SPECIFICS Phone: 908.874.2736 and/or separator and/or printer. 0.5 point hairline 5 point ITC Zapf Dingbats Bullet

printed at 85% Miconazole Nitrate Vaginal Insert (1200mg) Soft Gel Vaginal Insert FOR VAGINAL USE ONLY, DO NOT TAKE BY MOUTH.

Store at 20°-25°C(68°-77°F) - See enclosed leaflet

Distributed by: Personal Products Company Division of McNeil-PPC, Inc., Skillman, NJ 08558-9418 ©McNeil-PPC, Inc. 1999 Made in USA

LOT: SF106617 ere l H e EXP: 05/02 e P

Brand - Monistat File name - Mon1ComboBlisterLabel Design Agency Reference - SEVEN

Category - Dieline No. - n/a Project Name - n/a

Product Variant - 1 Combination Pack Barcode No. (+ BWR & Mag) - n/a Artwork program - Illustrator 8.0

Component Type - Blister Label Seven Job No. - 33845/284 Lead Mktg. Country - USA

Consumer Unit Contents - 1 Formulation No. - n/a Sales Region - North America

Copy & Graphics Number - xxxxxx / x Printer - PCI Manufacturing Site - n/a

GGM# / Version# - xxxx/ 3 No. of Colours - 1 Library - Local Market Artwork

Date - 6/21/01 Print Method - xxxxxx Keywords (Market) - xxxxxxx

Colors: 1 Fonts: Note: All colors for reference only, printer to use pre-approved color Optima / MathPi / Helv. Condensed drawdowns when printing. Family of Companies 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) BLACK ¥ This proof indicates approximate color only! ¥ 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: Bridget 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.

Date of issue: 0/00/01 Artwork Single Language

EXTERNAL VULVAR CREAM

Miconazole Nitrate Cream (2%) Center Front Center ORTHO Relieves External Vulvar Itching & Irritation Due to a Vaginal Yeast Infection Net Wt. 0.32 oz. (9 grams) For external vulvar use only. Do not take by mouth or use in eyes. Keep out of reach of children. Before using, read the enclosed leaflet for complete Directions and Warnings. Directions: To Open: Use cap to puncture seal. Squeeze a small amount of

cream onto your fingertip. Apply to skin outside the vagina (vulva) that 106-80-369-2 itches and is irritated. Use 2 times daily for up to 7 days, as needed. Tamper Resistant Feature: The tube opening should be sealed. Do not use 2.369 Slit Width 2.369 Slit

1.994 Deco Width 1.994 Deco if seal has been punctured or embossed design is not visible. Active Ingredient: miconazole nitrate 2%. See end of tube for lot number and expiration date. Covered under patent Number 5,514,698

Store at 20°-25°C (68°-77°F). .062 Center Back Center .25

Distributed by: Personal Products Company Division of McNeil-PPC, Inc., Skillman, NJ 08558 MADE IN U.S.A. ©McNeil-PPC, Inc. 2001 713980

.187 .187

Dieline reproduced from drawing no. A-TCL1053 .25 CCL Container Corp.

Title: 3/4 DIA. x 2-1/2 LG. length deco Max 1.875

For: Ortho length Tube 2.5

Date 4/14/00 length Repeat 2.563

Family of Companies

Brand - Monistat File name - MonExternalCrm.32ozTube Design Agency Reference - SEVEN

Category - Vaginal Antifungal Dieline No. - A-TCL1053 Project Name -

Product Variant - External Cream Barcode No. (+ BWR & Mag) - n/a Artwork program - Illustrator 8.0

Component Type - Tube Seven Job No. - 33845/284 Lead Mktg. Country - USA

Consumer Unit Contents - 0.32oz Formulation No. - n/a Sales Region - North America

Copy & Graphics Number - Printer - Margo Manufacturing Site - n/a

GGM# / Version# - /2 No. of Colours - 3 Library - Local Market Artwork

Date - 6/27/01 Print Method - Keywords (Market) -

Colors: 3 Fonts: AvantGarde-Book, Note: All colors for reference only, printer to use pre-approved color AvantGarde-Demi, AvantGarde-Medium, drawdowns when printing. Family of Companies Frutiger-Black, Frutiger-Bold, 199 Grandview Road Frutiger-Roman, GillSans-Bold, Helvetica, Skillman, NJ 08558-9418 Helvetica-Bold, Helvetica-Condensed, 908-874-1666 (Consumer Graphics Dept. Fax) Helvetica-Condensed-Bold, PANTONE¨ PANTONE¨ Black Helvetica-Narrow, Helvetica-Oblique ¥ This proof indicates approximate color only! 300 Cl Gry 10 ¥ All colors print 100% unless otherwise indicated. Substrate: ¥ 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

Date of issue: 0/00/01 Consumer Information Leaflet 000-00-000-0 /”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 Relieves External Vulvar Itching and Irritation Associated With a Yeast Infection

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 Monistat® 1 Combination Pack is a 1-dose Soft Gel Vaginal Insert lower abdominal, back or shoulder pain, foul-smelling vaginal or 3 in 6 months), you should talk to a doctor. discharge, or a missed period. These may be signs of a sexu- that cures most vaginal yeast infections, plus an external cream that Are vaginal yeast infections sexually transmitted? can be used for relief of itching and irritation on the skin outside the ally transmitted disease (STD) or a tubal pregnancy. If you have vagina (vulva) due to a yeast infection. Do not use Monistat® 1 these symptoms, call your doctor right away. Vaginal yeast infections are usually not spread by having intercourse (sex). However, if your partner has a rash, itching or dis- Combination Pack if this is the first time you have vaginal dis- What are other causes of a vaginal discharge? comfort in his genital area, he should contact a doctor to find out charge, itching, burning and discomfort. See your doctor or It is normal to have a small amount of vaginal discharge at cer- health professional first to find out the cause of your symptoms. the cause of his symptoms and tell the doctor that you are treating tain times of the month. This normal discharge may be clear or your vaginal yeast infection with Monistat® 1 Combination Pack. If a doctor has told you in the past that you had a vaginal yeast slightly white and does not cause itching, pain or a foul odor. infection and you have the same symptoms now (such as vaginal How can I prevent repeated vaginal yeast infections? discharge, itching or burning), then Monistat® 1 may work for you. The most common cause of an abnormal vaginal discharge is an infection. These infections include bacterial vaginosis (BV), tri- To lower your chances of getting another yeast infection: What is a vaginal yeast infection? chomoniasis (Trich), gonorrhea (GC) and/or chlamydia. All of these • Try to keep the genital area cool and dry. Yeast grow well in A vaginal yeast infection is a common condition caused by an may be transmitted sexually and are called sexually transmitted warm, moist areas. The following suggestions may be helpful: overgrowth of yeast (Candida) that may normally live in the vagina. diseases (STDs). If you have more questions about sexually trans- (1) Wear cotton underwear and loose-fitting clothes. Your doctor may call this infection "monilia" or "candidiasis." Some mitted diseases (STDs) call the CDC STD Hotline at 1-800-277-8922. (2) Change out of damp clothes or a wet bathing suit as soon as possible. women may have a yeast infection on the skin outside of the vagina Although many of the infections mentioned above can cause symp- (3) If you use minipads when you are not having a menstrual period, (vulva) at the same time that they have a vaginal infection. toms similar to a vaginal yeast infection (vaginal discharge, irritation and change the minipads often. itching), their diagnosis must be made by a doctor so that proper Who can get a vaginal yeast infection? treatment can be given. • Talk with your doctor about any drugs you are now taking. You 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 If these infections are not properly treated or if proper treatment is certain drugs such as antibiotics, steroids, or birth control pills. Do common during the childbearing years. Women who are pregnant or delayed, serious problems, such as pelvic inflammatory disease (PID) not stop taking these drugs without first asking your doctor. A diabetic, taking antibiotics, birth control pills or steroids, or who may result, which may prevent you from having children in the future. If 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 you are pregnant and do not get the proper treatment, the infection may other medical conditions such as diabetes or a weekened immune yeast infections that may not clear up easily with proper treatment. be passed to your baby before or during delivery and may cause your system. Some medical conditions can weaken the body’s normal ability baby to have permanent damage. If you have multiple sex partners or a to fight infection. One of the most serious of these conditions is new sex partner, you should also ask a doctor before use to make sure Can I use Monistat® 1 Combination Pack during my infection with the human immunodeficiency virus (HIV – the virus you do not have an STD. menstrual period? that causes AIDS). The HIV virus causes the body to be more likely Yes, this product can be used during your menstrual period. to get infections, including vaginal yeast infections that may not Why do women get repeated vaginal yeast infections? In fact, many women get vaginal yeast infections just before their clear up easily with proper treatment. If you may have been ex- Women may get repeated vaginal yeast infections that may not period because of hormonal changes. Using Monistat® 1 posed to HIV and get repeated vaginal yeast infections, you should clear up easily with proper treatment. Listed below are some of the Combination Pack during your period will not affect how well this see your doctor right away. For more information on HIV infection, causes of repeated yeast infections: product works. If you have started treatment and your period please contact your doctor or the CDC National AIDS HOTLINE. • hormonal changes occurring a few days before the monthly occurs, you should complete the full course of treatment. The CDC phone numbers are: 1-800-342-AIDS (English), 1-800- period 344-7432 (Spanish), or 1-800-243-7889 (hearing impaired, TDD). Do not use tampons while using this product, because tampons • use of antibiotics may remove some of the drug from the vagina. Use deodorant-free How can I tell if I have a vaginal yeast infection? • use of some birth control pills sanitary napkins or pads instead, and change them often. When you have a vaginal yeast infection, you may have one or • pregnancy Can I use other vaginal products with Monistat® 1 more of the following symptoms: • diabetes ("sugar" or "high blood sugar") Combination Pack? • vaginal itching • clothing – wearing tight layers or moist clothing in the genital area This drug should not be used with other vaginal products. • vaginal discharge that may be thick, white, and lumpy like • weakened immune system – some drugs (such as chemother- cottage cheese • Douches and tampons may remove some of the Soft Gel Vaginal apy or steroids) and medical conditions can weaken the body’s Insert from the vagina. • vaginal soreness, irritation, or burning normal ability to fight infection. One of the most serious of these • Spermicides may interfere with Monistat® 1 Combination Pack. • rash or redness on the skin outside the vagina (vulva) conditions is infection with the human immunodeficiency virus • Condoms and diaphragms may be damaged by this product and • burning on urination (HIV – the virus that causes AIDS). Infection with HIV causes the person to be more likely to get infections, including vaginal yeast infections. fail to prevent pregnancy or sexually transmitted diseases (STDs). • painful vaginal intercourse (sex)

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

Category - Dieline No. - n/a Project Name - n/a

Product Variant - 1 Combination Pack Barcode No. (+ BWR & Mag) - n/a Artwork program - Illustrator 8.0

Component Type - Insert Seven Job No. - 34649/336 Lead Mktg. Country - USA

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

Copy & Graphics Number - xxxxxx / x Printer - n/a Manufacturing Site - n/a

GGM# / Version# - xxxx/ 4 No. of Colours - 2 Library - Local Market Artwork

Date - 6/27/01 Print Method - xxxxxx Keywords (Market) - xxxxxxx

Colors: 2 Fonts: Note: All colors for reference only, printer to use pre-approved color Optima / MathPi / Helv. Condensed drawdowns when printing. Family of Companies 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: Bridget Motley ¥ All trapping is the responsibility of the engraver and/or separator and/or printer. ARTWORK SPECIFICS Phone: 908.874.2736

Date of issue: 0/00/01 How can I get the best results when treating my infection? ® Directions for using the External Vulvar Cream • Use the Soft Gel Vaginal Insert at bedtime, even during your How Should I Use Monistat 1 Use the cream twice daily, for up to 7 days as needed. menstrual period. Combination Pack? 1. Open the tube by unscrewing the cap. The first time the • Use the tube of cream externally only while symptoms are pre- This product is for adults and children 12 years of age tube is opened, press the sharp point of the cap into the sent. If you have symptoms (such as itching and irritation) on the and over. For children under 12 years, ask a doctor. sealed end of the tube. Push skin outside the vagina (vulva), apply the cream externally 2 times down firmly until the seal is open. a day, up to a total of 7 days, as needed. Directions for using the Soft Gel Vaginal Insert. 2. Squeeze a small amount of • Dry the genital area thoroughly after a shower, bath or swim. Begin treatment before going to bed: 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 skin outside the vagina (vulva) yeast. 1 Separate the that itches and is irritated. • Wear cotton underwear and loose-fitting clothes. paper backing from 4. Screw the cap back on the tube. 5. Repeat steps 2 – 4 each morning • Wipe from front to back after a bowel movement or after urination. blister pack by peel- ing back the cover and at bedtime for up to 7 days, as needed. • Do not douche, because douching may wash the drug out of the from the corner vagina. (see picture). PAPER BACKING When using this product: • Do not use tampons, because they remove some of the drug from • do not use tampons, douches, spermicides, or other vaginal prod- the vagina. Use deodorant-free sanitary napkins or pads as ucts. Condoms and diaphragms may be damaged and fail to prevent needed. pregnancy or sexually transmitted diseases (STDs). SOFT GEL Place the • Do not use spermicides, as they may interfere with Monistat® 1 VAGINAL 2 • do not have vaginal intercourse INSERT Soft Gel Vaginal Combination Pack. Insert firmly into the • mild increase in vaginal burning, itching or irritation may occur ® • Do not have vaginal intercourse while using Monistat 1 APPLICATOR top (wider end) of Stop use and ask your doctor if: BARREL the applicator so it Combination Pack. • symptoms do not get better in 3 days will not fall out. • Do not scratch the skin outside the vagina. Scratching can cause • symptoms last more than 7 days more irritation and can spread the infection. • you get a rash or hives, abdominal pain, fever, chills, nausea, • Tell your doctor about any drugs you are now taking. Certain PLUNGER vomiting, or foul-smelling vaginal discharge. drugs such as antibiotics, steroids, and birth control pills, may These may be signs that this product is not working, or you make it more likely for you to get a vaginal yeast infection. If you Hold the applicator containing the Soft Gel may have a more serious condition or an allergic reaction. are taking any of these drugs do not stop taking them without first 3 Vaginal Insert by the opposite end from where the asking a doctor. If pregnant or breast-feeding, ask a health professional before use. Soft Gel Vaginal Insert is. Keep out of reach of children. If swallowed, get medical help or • If you have any other medical questions or concerns about contact a Poison Control Center right away. vaginal yeast infections, call your doctor. ® ® 4 Gently insert the ap- What side effects may occur with Monistat 1 Combination Pack? What warnings should I know about when using Monistat 1 plicator into the vagina as Combination Pack? A mild increase in vaginal burning, itching, or irritation may occur far as it will go comfortably. UTERUS when the Soft Gel Vaginal Insert is inserted. Abdominal cramping has For vaginal use only. This can be done while also been reported. URINARY Do not use if you have never had a vaginal yeast infection lying on your back with OPENING Stop using Monistat®1 Combination Pack and consult your doctor if diagnosed by a doctor. your knees bent (as shown VAGINA CERVIX you have abdominal pain, hives, skin rash, or if you have severe vaginal in picture) or while stand- burning, itching, or irritation or swelling. Ask a doctor before use if you have: RECTUM ing with your feet apart and ® • vaginal itching and discomfort for the first time. You may need knees bent. What should I do if I have questions about Monistat 1 a different treatment. Combination Pack? • lower abdominal, back or shoulder pain, fever, chills, nausea, Questions of a medical nature should be taken up with your doctor. vomiting, or foul-smelling vaginal discharge. You could have 5 With one hand holding the barrel, use the other hand 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 a more serious condition. to push the plunger all the way in to place the Soft Gel Vaginal Insert as far back in the vagina as possible. Then Eastern time, Monday through Friday. A nurse will gladly answer your • vaginal yeast infections often (such as once a month or remove both parts of the applicator from the vagina. questions. Our toll-free number is 1-877-MONISTAT (1-877-666-4782). 3 in 6 months). You could be pregnant or have a serious underly- Other Information: ing medical cause for your symptoms, including diabetes or a 6 Throw away applicator after use. Do not flush in toilet. • packing tray inside this carton is secured with a printed seal. Do not weakened immune system. use if seal has been either removed or broken. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS. 7Lie down as soon as possible after inserting the Soft • do not use if wrapper is missing or damaged (Soft Gel Vaginal Insert Ask a doctor or pharmacist before use if you are taking the perscrip- Gel Vaginal Insert. This will reduce leakage. is individually wrapped). tion blood thinning medicine, warfarin (coumadin), • do not use if tube seal has been punctured or embossed design You may want to use deodorant-free pads or because bleeding or bruising may occur. symbol is not visible. pantyshields to protect your clothing during the time that • store at 20° – 25° C (68° – 77° F) you are using Monistat® 1 Combination Pack. This is because the Soft Gel Vaginal Insert can leak or you may Active ingredients: Soft Gel Vaginal Insert: miconazole nitrate, 1200 mg. Distributed by: External Vulvar Cream – miconazole nitrate, 2%. Personal Products Company get some discharge. Do not use tampons, douches, 6-DIGIT Inactive ingredients: Soft Gel Vaginal Insert: gelatin, glycerin, lecithin, BAR CODE Division of McNeil-PPC, Inc. spermicides, condoms or diaphragms until after you 1/2” HEIGHT Skillman, NJ 08558 have completed the treatment and your symptoms are mineral oil, titanium dioxide, white petrolatum. External Vulvar Cream: ©McNeil-PPC, Inc. 2001 XXX-XX-XXX-X gone. benzoic acid, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.