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 I 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 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 Insert (1200mg) Nitrate Vaginal COMBINATION PACK COMBINATION AND EXPIRATION DATE AND EXPIRATION COMBINATION PACK LOCATION OF LOT# LOCATION VAGINAL ANTIFUNGAL VAGINAL and Miconazole Nitrate Cream (2%) Miconazole Nitrate Vaginal Insert (1200mg) Miconazole Nitrate Cream (2%) and and Miconazole Nitrate Cream (2%) 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 C • • 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 drawdowns when printing. Minion Bold, Helvetica Bold JOHNSON & JOHNSON 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