NDA 20-574
`
`Enclosure: Attachment A:
`
`Approved labeling text for the carton and educational brochure.
`
`Attaclnnent B:
`
`Approved labeling text for the tube.
`
`Attachment C:
`
`Approved labeling text for the carton and educational brochure, to
`be used after 6 months following approval of this application Or at the
`next printing of the product labeling, whichever comes first.
`
`Attachment D:
`
`Approved labeling text for the tube, to be used after 6 months
`following approval of this application or at the next printing of the
`product labeling.
`
`Page 1 of21
`
`Kaken Exhibit 2068
`
`Acrux V. Kaken
`
`IPR2017-00190
`
`

`

`3-Day
`Treatment
`
`‘
`
`3-Day
`Treatment
`
`3-Day
`Treatment
`
`Attachment A:
`
`tiangmglaa
`
`M
`
`Gyne-Lotrimin 3 ‘9
`Clotrimazole Vaginal Cream (2%)
`Vaginal Aniifungal
`3 Disposable Applicators
`
`Emmfiausl
`
`Cures Most Vaginal Yeast Infections
`
`Gyne-Lotrimin 3 °
`Clotrimazole Vaginal Cream (2%)
`Vaginal Antifungal
`
`Educational Brochure Enclosed
`
`One 219 (0.74 oz.) Tube of Vaginal Cream
`(Clotrimazole (2%) (100 mg per applicator)
`and 3 Disposable Applicators
`
`Schenng-Plough logo
`
`W C
`
`ures Most Vaginal Yeast Infections
`
`Gyne-Lotrimin 3 °
`Clotrimazole Vaginal Cream (2%)
`Vaginal Antifungal
`3 Disposable Applicators
`
`Page 2 0f21
`
`

`

`Egfiom Panel
`
`Cures Most Vaginal Yeast Infections
`
`Gyne-Lotrimin 3 “9
`Clotrimazole Vaginal Cream (2%)
`Vaginal Antifungal
`3 Disposable Applicators
`
`.Sjsteflanela
`
`Cures Most Vaginal Yeast infections
`
`Gyne-Lotrimin 3 °
`Clotrimazole'Vaginal Cream (2%)
`Vaginal Antifungal
`3 Disposable Applicators
`
`mm
`
`Gyne-Lotrimin 3 °
`Clotrimazole Vaginal Cream (2%)
`Vaginal Antifungai
`.
`3 Disposable ApplicatOrs
`
`Cures Most Vaginal Yeast Infections
`
`3-Day
`Treatment
`
`3-Day
`Treatment
`
`3-Day
`Treatment
`
`GYNE-LOTRIMIN 3 ° Vaginal Cream is a 3-day treatment that cures most vaginal
`.
`yeast infections.
`If this is the flat time you have had vaginal itching and
`discomfort. consult your doctor.
`if you have had a doctor diagnose a vaginal yeast
`infection before and have the same symptoms now, use this cream as directed for 3
`days in a row.
`
`Active Ingredient: Clotrimazole (2%) (100 mg per applicator).
`
`Use:
`c For the treatment of vaginal yeast infections (candidiasis).
`
`Warnings:
`- For vaginal use only. Do not use in eyes or take by mouth.
`- Do not use GYNE-LOTRIMIN 3 Vaginal Cream if you have any of the
`following signs and symptoms:
`
`Page 3 0f21
`
`

`

`-
`
`-
`
`fever (higher than 100°F).
`-
`pain in the lower abdomen, back, or either shoulder.
`-
`a foul-smelling vaginal discharge.
`-
`- While using GYNE-LOTRIMIN 3 Vaginal Cream, if you get a fever. abdominal
`pain. or a foul-smelling vaginal discharge, stop Using the product and
`contact your doctor right away. You may have a more serious illness.
`If your symptoms do not improve in 3 days, or you still have symptoms after 7
`days, you should call your doctor.
`If your symptoms return within 2 months, you should consult your doctor.
`You could be pregnant or there could be a serious underlying medical cause
`for your symptoms, including diabetes or a weakened immune system (which
`may be due to HIV - the virus that causes AIDS).
`- Contact your doctor if you get hives or a skin rash while using this product.
`~ Do not use tampons, douches. or spermicides while using this product.
`- Do not rely on condoms or diaphragms to prevent sexually transmitted
`diseases or pregnancy. This product may damage condoms and diaphragms
`and cause them to fail.
`If pregnant or breast-feeding, ask a health professional before use.
`-
`- Do not use in girls less than 12 years of age.
`‘
`If swallowed, get
`o Keep this and all drugs out of the reach of children.
`medical help or contact a Poison Control Center right away.
`
`Directions:
`Applicator and instructions are enclosed.
`-
`Before using, read the enclosed brochure for complete instructions.
`-
`To open: use cap to puncture seal.
`o
`Insert one applicatorful of cream into the vagina at bedtime for 3 days in a
`row.
`
`Inactive Ingredients: Benzyl alcohol, cetearyl alcohol, cetyl esters wax,
`octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
`
`Store at room temperature 15° - 30°C (59° - 86°F). Avoid heat over 30°C or
`86°F.
`
`See end flap of carton and end of tube for lot number and expiration date.
`
`Wm; Do not purchase if carton is opened. The tube opening should be
`sealed.
`If seal has been punctured or the embossed design SP is not visible, do
`not use the product. Retum the product to the store where you bought it.
`
`Page 4 of21
`
`

`

`If you have any ottier
`Medical questions should be answered by your doctor.
`questions. or need more information on this product, cali our TOLL-FREE
`Number, at 1-8XX-(XXX-XXXX), between 8:00 am. and 5:00 pm. Eastern
`Standard Time, Monday through Friday.
`
`© 1998 Distributed by Schering-Plough HealthCare Products, Inc., Memphis, TN
`38151 U.S.A. All rights reserved. Made in USA.
`
`Page 5 0f21
`
`

`

`Educational Brochure
`
`Read This Before Using
`
`Gyne—Lotn‘min 3 "
`Clotrimazole Vaginal Cream (2%)
`Vaginal Antifungal
`
`Clotrimazole (2%) (100 mg per applicator).
`
`3-day treatment of vaginal yeast infections (Candidasis)
`
`Schering-Plough logo
`
`Use:
`o
`
`For the treatment of vaginal yeast infections (candidiasis).
`
`If you have symptoms such as vaginal itching. burning, or discharge, and if at some
`time in the past your doctor has told you that these symptoms were due to a vaginal
`yeast infection, then GYNE-LOTRIMIN 3 Vaginal Cream should work for you.
`if,
`however, you have never had these symptoms or a vaginal yeast infection before,
`you should see your doctor before using this product.
`
`What Is A Vaginal Yeast Infection (Candldiasis)?
`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. 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 may have a yeast
`infection on the skin outside the vagina (vulva) associated with the vaginal infection.
`A yeast infection can occur at any age. It is most common during the
`childbearing years. Women who are pregnant or diabetic, taking antibiotics. birth control
`pills or steroids. or who have a weakened immune system are more likely to get
`repeated yeast infections.
`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
`immune—deficiency virus (HIV - the virus that causes AIDS). The HIV virus causes the
`body to be more likely to get infections. including vaginal yeast infections. Therefore,
`women with HIV infection may have frequent vaginal yeast infections that do not clear
`up easily with proper treatment.
`If you may have been exposed to HIV and are
`experiencing repeated vaginal yeast infections, y0u should see your doctor right away.
`For additional information on HIV infection, please contact your doctor or the CDC
`National AlDS HOTLINE. The CDC phone numbers are: 1-800-342-AlDS (English). 1-
`800-344-7432 (Spanish). or 1«800-243-7889 (hearing impaired, TDD).
`v
`
`1
`
`Page 6 0f21
`
`

`

`Symptoms of A Vaginal Yeast Infection
`There-are many signs and symptoms of a vaginal yeast infection. They can
`include:
`-
`Vaginal itching (ranging from mild to severe).
`A clumpy. vaginal discharge that may look like Cottage cheese.
`Vaginal soreness. irritation. or burning.
`Rash or redness on the skin outside the vagina (vulvar irritation).
`
`Note: Vaginal diSCharge that is different from above, for example, a yellow/green
`discharge or a foul—smelling discharge may mean that you have a different infection. If
`this is the case, you should consult your doctor before using GYNE-LOTRIMIN 3
`Vaginal Cream.
`
`Warnings
`
`- For vaginal use only. Do not use in eyes or by mouth.
`- This product is effective only in treating vaginal yeast infections.
`- Do not use GYNE-LOTRIMIN 3 Vaginal Cream if you have any of the following signs
`and symptoms:
`'
`V
`)-
`fever (higher than 100°F).
`-
`pain in the lower abdomen, back, or either shoulder.
`-
`a foul-smelling vaginal discharge.
`- While using GYNELOTRIMIN 3 Vaginal Cream, if you get a fever, abdominal pain,
`or a foul—smelling vaginal discharge, stop using the product and contact your
`doctor right away: You may have a more serious disease.
`if your symptoms do not improve in 3 days, or you still have symptoms after 7 days,
`you should call your doctor.
`If your symptoms return within 2 months, you should consult your doctor. You could
`be pregnant or there could be a serious underlying medical cause for your infections,
`including diabetes or a weakened immune system (which may be due to HiV - the
`virus that causes AIDS).
`- Contact your doctor if you get hives or a skin rash while using this product.
`- Do not use tampons. douches, or spermicides while using this medicine.
`. Do not rely on condoms or diaphragms to prevent sexually transmitted diseases or
`pregnancy. This product may damage condoms and diaphrang and cause them to
`fail.
`
`o
`
`-
`
`If pregnant or breast-feeding, ask a health professional before use.
`o
`- Do not use in girls less than 12 years of age.
`0 Keep this and all drugs out of the reach of children.
`help or contact a Poison Control Center right away.
`
`If swallowed, get medical
`
`Adverse Reactions (Side Effects)
`
`A mild increase in vaginal burning, itching, or irritation may occur when GYNE-
`LOTRlMlN 3 Vaginal Cream is inserted. Stop using GYNE-LOTRIMlN 3 Vaginal Cream
`
`2
`
`Page 7 0f21
`
`

`

`and consult your doctor if you have abdominal pain, hives. or skin rash, or if you have
`severe vaginal burning, itching. or irritation.
`
`For Best Results
`
`1. Be sure to use this product for the full 3 days, even if your symptoms go away
`soonen
`2. Use one applicatorful of GYNE-LOTRIMIN 3 Vaginal Cream at bedtime for three
`days in a row, even during your menstrual period.
`3. Wear cotton undenivear.
`4.
`If your partner has itching, redness or discomfort of his penis, he should consult his
`doctor. He should tell the doctor that you are treating yourself for a vaginal yeast
`infection.
`.
`5. Dry the outside vaginal area thoroughly afler a shower, bath or swim. Change out of
`a wet bathing suit or damp clothes as soon as possible. A dry area is less likely to lead
`to the growth of yeast.
`,
`6. Wipe from front to rear after a bowel movement or urination.
`7. Do not douche unless your doctor tells you to do so. Douching may wash the
`product out of the vagina.
`~
`8. Try not to scratch the skin outside the vagina. Scratching can cause more irritation
`and can spread the infection.
`9. Discuss with your doctor any dnJgs you are now taking. You are more likely to get a
`vaginal yeast infection with certain drugs.
`10. Do not have vaginal intercourse while using this product.
`
`If You Have A Question
`if you have any
`Questions of a medical nature should be taken up with your doctor.
`other questions, or need more information on this product. call our TOLL-FREE
`Number, at 1-8XX-(XX)0(XXX), between 8:00 am. and 5:00 pm. Eastern Standard
`Time. Monday though Friday.
`
`‘ Active Ingredient
`H‘Clotrimazole (2%)
`
`Inactive Ingredients
`Benzyl aloohoi, cetearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60,
`purified water, sorbitan monostearate.
`
`Storage
`Store at room temperature 15° - 30°C (59° - 86°F). Avoid heat over 30°C or 86°F.
`See and flap of carton and end of tube for lot number and expiration date.
`
`© 1998 Distributed by Schering-Plough HealthCare Products, lnc., Memphis, TN
`38151 USA. All Rights Reserved. Printed in USA.
`
`Page 8 of21
`
`

`

`How to use GYNE—LOTRIMIN 3 Vaginal Cream with 3 disposable
`applicators.
`
`Directions for Use
`
`Use the cream at bedtime for 3 days in a row.
`Read the full directions below before using.
`
`1. To open the tube, unscrew the cap. Press the sharp point of the cap into the sealed
`end of the tube. Push down firmly until the seal is broken. (See picture.)
`
`{2 pictures:
`
`a 2 hands unscrewing the cap from a tube of cream
`- 2 hands used to break the seal at the end of the tube}
`
`2. Attach the applicator to the tube of cream by placing “A” end of the applicator firmly
`onto tube of cream. (See picture.)
`
`{picture showing thepapplicator being firmly attached to the tube, label the “A”
`end of the tube}
`'
`
`3. Gently squeeze the cream into the applicator, continue sdueezing until line on
`plunger marked "FULL" reaches end of barrel. Separate the applicator from the tube.
`After each use, replace cap and roll up the tube from the bottom.
`
`{picture showing the applicator being filled by squeezing the tube from the
`bottom. Identify the plunger and the barrel of the applicator in this same picture}
`
`4. Hold the barrel as shown in the picture.
`
`{picture with a hand holding the barrel}
`
`5. The Gyne«Lotn'min 3 Vaginal Cream applicator is inserted into the vagina in much the
`same way as a tampon. Gently insert the applicator into the vagina as far back as it will
`go comfortably. This can be done while lying on your back with your knees bent (as
`shown in the picture). or while standing with your feet apart and your knees bent.
`
`{picture showing recumbent position. Show frontal view of the human anatomy: vagina
`and urinary opening. Side view would show vagina, urinary opening. and rectum and
`where the applicator would be inserted. Place an X over the urinary opening and rectum
`to indicate where the applicator should not be inserted}
`r
`
`6. With one hand holding the barrel. use the other hand to push the plunger into the
`barrel as far as it will go. Remove the applicator from the vagina.
`
`Page 9 0f21
`
`

`

`7. Throw the applicator away after each use. Do not flush it down the toilet.
`
`8. Lie down as soon as possible to keep the cream from leaking out.
`
`9. Repeat steps 2 through 8 with a new applicator before bedtime for the next 2 days.
`
`To protect your clothing from leakage or discharge, you may want to use deodorant-free
`pads or panty shields while you are using Gyne-Lotrimin 3 Vaginal Cream. Do not use
`tampons, douches, or spermicides until after you have completed the treatment and
`your symptoms are gone.
`
`U1
`
`Page 10 of21
`
`

`

`
`
`I
`
`<m (
`
`I < c
`
`: m L
`
`U D O O —
`
`
`
`
`
` 9N.LVOOON
`
`2 O OI .
`
`0
`-<
`
`Z O Oo r
`
`. O:
`
`3
`
`I Il
`
`:l
`I
`
`Attachment B:
`
`150%
`
`I :
`
`5"
`refine/Mm:
`EGme-lolflhI/h m,
`
`flea/mail!
`
`llf/fl/A’d‘ll
`[laminae/e
`flfi'é‘yaé’b‘ért’ffinor’féftfi‘é’y‘é’h
`III/.47 WE/GHf27g (0. 74 oz.)
`;
`.
`V
`'
`:To Open: Use cap to puncture seat,
`Intrections: Fit] the applicator and mean one apphcatortut of cream Into the.
`Mom once a day. perterably at bedtime. Repeat this procedure dain for 3:
`.consecutive days.
`r
`'WABNING: Read the Warning tntormation on the carton or In the educationelt
`.pempblet betore using this product.
`'Satety Sealed: The tube 0 eninp should be sealed. It tea! has been
`:punetured orttre embossed eetpn SPis not visible. do not use product.
`IActive Ingredient: Clotrirnazole 2%.
`{Store et room temperature between 15° and 30°C (59° and 86°F).
`uSee tube crimp for lot number and expiration date.
`:
`'01998 Distributed by Scheriniq-Ptough HealthCere Products. Inc.
`20904607I
`LMernphis. TN 38151 U.S.A. All
`ighte Reserved Made In USA
`-—__—-.._—_.._..- _-_——_-__-..______-_—_--__——-
`
`ammo. Mlde In 03‘
`
`. . -
`
`7'
`— _ _ - . ~ _ — _ u - v — _ _ - - w — — a - - r — — u - - v — - - u v — _-.l
`
`MIMI/h
`
`£th
`
`g
`Fed/mill
`355555557
`.
`ffifi‘v‘b‘éérfi‘fin°5§s"rfi"s’r‘é’£;
`. NET Wf/GHTZU (0.74021)
`‘
`:To Open. Use cap to puncture seal.
`IDlreetlene: FIII the Ippllcetor end insert one epotlcetonul of cream Into the:
`{veetne once e day. perterebly at bedtime. Reoeet true procedure dilly lot 3:
`.coneecutive days.
`.
`'WAHNING: Reed the Werntnp Intennetlen on the eerten or In the educetlenel'
`.pemptrlet before uetne urn preduet.
`,
`'SeIet' Seeted: The tube 0 win: would be eeeled.
`II eeeI tre- beenl
`'punetured er the mound eeipn 3P Ie netvleIhle. on net uee product.
`:
`lAetlrle Ingredient: CIoIrImezuIe 27“
`Stere at teen! tern ereture between 15' end 30°C (59° end SSW).
`ISee tube crtmp tor [gt number and etplretlon data.
`Istrtbuted b SaherIn -Pleugh Heltthcern Predum Inc.
`
`I .
`
`SN.0100ON
`
`TYPE SIZES ARE 6 POINTS AND LARGER
`
`'13we
`iNOHd
`
`WBNVd
`
`Page 11 0f21
`
`

`

`Attachment C:
`
`We
`
`9311521
`
`Gyne-Lotrimin 3 “9
`Ciotrimazoie Vaginal Cream (2%)
`Vaginal Antifungal
`
`Vaginal Cream (in graphic bar)
`
`From Bagel
`
`Cures Most Vaginal Yeast Infections
`
`Gyne-Lotrimin 3 0
`Clotrimazoie Vaginal Cream (2%)
`Vaginal Antifungal
`
`Vaginal Cream (in graphic bar)
`
`Educational Brochure Enclosed
`
`3-Day
`Treatment
`3 Disposable Applicators
`
`3-Day
`Treatment
`
`One 219 (0.74 oz.) Tube of Clotrimazole Vaginal Cream (2%) and 3 Disposable
`Applicators
`
`Schering-Plough logo
`
`graphic of Gyne-Lotrimin 3 tube with 3 applicators
`
`IQEPjnfil
`
`‘ Cures Most Vaginal Yeast Infections
`
`Gyne-Lotrlmln 3 4°
`Clotrirnazoie Vaginal Cream (2%)
`Vaginal Antifungal
`
`Vaginal Cream (in graphic bar)
`
`3-Day
`Treatment
`3 Disposable Applicators
`
`Page 12 of21
`
`

`

`3-Day
`Treatment
`
`3 Disposable Applicators
`
`3-Day
`Treatment
`
`3 Disposable Applicators
`
`3-Day
`
`Treatment
`
`3 Disposable Applicators
`
`W C
`
`ures Most Vaginal Yeast Infections
`
`Gyne-Lotrimin 3 °
`Clotrimazole Vaginal Cream (2%)
`Vaginal Antifungal
`
`Vaginal Cream (in graphic bar)
`
`Side Eaneis
`
`Cures Most Vaginal Yeast Infections
`
`Gyne-Lotrimin 3 0
`Clotrirnazole Vaginal Cream (2%)
`Vaginal Antifungal
`
`Vaginal Cream (in graphic bar)
`
`gagkfiansl
`
`Gyne-Lotrimin 3 9.
`Clotrimazole Vaginal Cream (2%)
`Vaginal Antifungal
`
`Vaginal Cream (in graphic bar)
`
`GYNE-LOTRIMIN 3 0 Vaginal Creamis a 3-day treatment that cures most vaginal
`yeast infections.
`If this is the first time you have had vaginal itching and
`discomfort, talk to your doctor.
`if you have had a doctor diagnose a vaginal yeast
`infection before and have the same symptoms now, use this cream as directed for 3
`days in a row.
`
`Active Ingredient: Clotrimazole 2% (100 mg per applicator).
`
`Use:
`- For the treatment of vaginal yeast infections (candidiasis).
`
`Warnings:
`o For vaginal use only. Do not use in eyes or take by mouth.
`
`[0
`
`Page 13 0f21
`
`

`

`o
`
`-
`
`o Do not use GYNE-LOTRlMIN 3 Vaginal Cream if you have any of the
`following symptoms:
`-
`fever (higher than 100°F).
`o
`pain in the lower abdomen, back, or either shoulder.
`o
`a foul-smelling vaginal discharge.
`0 While using GYNE-LOTRlMlN 3 Vaginal Cream, if you get a fever. abdominal
`pain. or a foul-smelling vaginal discharge. stop using the product and
`contact your doctor right away. You may have a more serious illness.
`If your symptoms do not improve in 3 days, or you still have symptoms after 7
`days, you should talk to your doctor.
`If your symptoms return within 2 months, you should talk to your doctor. You
`could be pregnant or there could be a serious underlying medical cause for
`your symptoms. including diabetes or a weakened immune system (which
`may be due to HIV —— the virus that causes AIDS).
`- Contact your doctor if you get hives or a skin rash while using this product.
`o Do not use tampons, douches. or spermicides while using this product.
`o Do not rely on condoms or diaphragms to prevent sexually transmitted
`diseases or pregnanCy. This product may damage condoms and diaphragms
`and cause them to fail.
`lf pregnant or breast-feeding, ask a health professional before use.
`-
`- Do not use in girls less than 12 years of age.
`If swallowed. get
`- Keep this and all drugs out of the reach of children.
`medical help or contact a Poison Control Center right away.
`
`Directions:
`
`Applicator and instructions are enclosed.
`-
`Before using. read the enclosed brochure for complete instructions.
`c
`To open: use cap to puncture seal.
`-
`Insert one applicatorful of cream into the vagina at bedtime for 3 days in a
`row.
`
`Inactive Ingredients: Benzyl alcohol, cetearyl alcohol, cetyl esters wax.
`octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
`
`Store at room temperature 15° - 30°C (59° - 86°F). Avoid heat over 30°C or
`86°F.
`
`See end flap of carton and end of tube for lot number and expiration date.
`
`If seal has been broken or the
`important; The tube opening should be sealed.
`embossed design SP is not visible, do not use the product. Return the product
`to the store where you bought it.
`
`if you have any other
`Medical questions should be answered by your doctor.
`questions, or need more information on this product, call our TOLL-FREE
`
`Page 14 of21
`
`

`

`between 8:00 am. and 5:00 pm. Eastern
`Number, at 1-8XX-(XXX-XXXX
`Standard Time, Monday through Friday.
`
`© 1998 Distributed by Schering-Plough HealthCare Products, Inc., Memphis, TN
`38151 USA. All rights reserved. Made in USA.
`
`Page 15 0f21
`
`

`

`Educational Brochure
`
`Read This Before Using
`
`Gyne-Lotrimin 3 O
`Clotrimazole Vaginal Cream (2%)
`Vaginal Antifungal
`
`Clotrimazole 2% (100 mg per applicator).
`
`3-day treatment of vaginal yeast infections (Candidasis)
`
`Schering-Plough logo
`
`Use:
`-
`
`For the treatment of vaginal yeast infections (candidiasis).
`
`If you have symptoms such as vaginal itching, burning, or discharge, and if at some
`time in the past your doctor has told you that these symptoms were due to a vaginal
`yeast infection, then GYNEVLOTRIMIN 3 Vaginal Cream should work for you.
`If,
`however, you have never had these symptoms or a vaginal yeast infection before,
`you should see your doctor before using this product.
`
`What Is A Vaginal Yeast Infection (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. 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 may have a yeast
`infection on the skin outside the vagina (vulva) associated with the vaginal infection.
`A yeast infection can occur at any age. It is most common during the
`childbearing years. Women who are pregnant or diabetic, taking antibiotics, birth control
`" pills or steroids, or who have a weakened immune system are more likely to get
`repeated yeast infections.
`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 (HlV - the virus that causes AIDS). The HIV virus causes the
`body to be more likely to get infections. including vaginal yeast infections. Therefore.
`women with HIV infection may have frequent vaginal yeast infections that do not clear
`up easily with proper treatment.
`If you may have been exposed to HIV and are
`experiencing repeated vaginal yeast infections, you should see your doctor right away.
`For additional information on HIV infection, please contact your doctor or the CDC
`National AIDS HOTLINE. The CDC phone numbers are: 1-800~342-AIDS (English), 1‘
`800-344—7432 (Spanish). or 1—800-243-7889 (hearing impaired, TDD).
`'
`
`1
`
`Page 16 0f21
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`

`

`Symptoms of A Vaginal Yeast Infection
`There are many symptoms of a vaginal yeast infection. They can include:
`Vaginal itching (ranging from mild to severe).
`A clumpy, vaginal discharge that may look like cottage cheese.
`Vaginal soreness, irritation, or burning.
`Rash or redness on the skin outside the vagina (vulvar irritation).
`
`C O U Q
`
`Note: Vaginal discharge that is different from above, for example, a yellow/green
`discharge or a foul~smelling discharge may mean that you have a different infection. If
`this is the case, you should talk to your doctor before using GYNE-LOTRIMIN 3
`Vaginal Cream.
`
`Warnings (this section can be shaded but not boxed)
`
`For vaginal use only. Do not use in eyes or by mouth.
`This product is effective only in treating vaginal yeast infections.
`Do not use GYNE-LOTRIMIN 3 Vaginal Cream if you have any of the following
`symptoms:
`fever (higher than 100°F).
`-
`pain in the lower abdomen, back, or either shoulder.
`-
`a foul-smelling vaginal discharge.
`"
`While using GYNE-LOTRIMIN 3 Vaginal Cream, if you get a fever, abdominal pain,
`or a foul-smelling vaginal discharge, stop using the product and contact your
`doctor right away. Y0u may have a more serious disease.
`If your symptoms do not improve in 3 days, or you still have symptoms after 7 days,
`you should talk to your doctor.
`If your symptoms return within 2 months, you should talk to your doctor. You could
`be pregnant or there could be a serious underlying medical cause for your infections,
`including diabetes or a weakened immune system (which may be due to HIV - the
`virus that causes AIDS).
`Contact your doctor if you get hives or a skin rash while using this product.
`Do not use tampons, douches, or spermicides while using this medicine.
`Do not rely on condoms or diaphragms to prevent sexually transmitted diseases or
`pregnancy. This product may damage condoms and diaphragms and cause them to
`fail.
`If pregnant or breast-feeding. ask a health professional before use.
`Do not use in girls less than 12 years of age.
`Keep this and all drugs out of the reach of children.
`help or contact a Poison Control Center right away.
`
`If swallowed, get medical
`
`Side Effects
`
`A mild increase in vaginal burning, itching, 0r irritation may occur when GYNE-
`LOTRIMIN 3 Vaginal Cream is inserted. Stop using GYNE-LOTRIMIN 3 Vaginal Cream
`and talk to your doctor if you have abdominal pain, hives, or skin rash, or if you have
`2
`
`Page 17 0f21
`
`

`

`severe vaginal burning, itching, or irritation.
`
`For Best Results
`
`1. Be sure to use this product for the full 3 days, even it your symptoms go away
`sooner.
`2. Use one applicatorful of GYNE-LOTRIMIN 3 Vaginal Cream at bedtime for three
`days in a row, even during your menstrual period.
`3. Wear cotton underwear.
`4.
`If your partner has itching, redness or discomfort of his penis, he should consult his
`doctor. He should tell the doctor 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 clothes as soon as possible. A dry area is less likely to lead
`to the growth _of yeast.
`6. Wipe from front to rear after a bowel movement or urination.
`7. Do not douche unless your doctor tells you to do so. Douching may wash the
`product out of the vagina.
`8. Try not to scratch the skin outside the vagina. Scratching can cause more irritation
`and can spread the infection.
`9. Discuss with your doctor any drugs you are now taking. You are more likely to get a
`vaginal yeast'infectlon with certain drugs.
`10. Do not have vaginal intercourse while using this product.
`
`If You Have A Question
`If you have any
`Questions of a medical nature should be taken up with your doctor.
`other questions, or need more information on this product, call our TOLL-FREE
`Number, at 1'-8xx-(XXXX.XXX), between 8:00 am. and 5:00 pm. Eastern Standard
`Time, Monday though Friday.
`
`« Active Ingredient
`Clotrimazole 2% (100 mg per applicator)
`
`Inactive Ingredients
`Benzyl alcohol. cetearyl alcohol, cetyl esters wax, octyldodecanol. polysorbate 60,
`purified water, sorbitan monostearate.
`
`Storage
`Store at room temperature 15° - 30°C (59° « 86°F). Avoid heat over 30°C or 86°F.
`See end flap of carton and end of tube for lot number and expiration date.
`
`© 1998 Distributed by Schering—Plough HealthCare Products, Inc., Memphis, TN
`38151 USA. All Rights Reserved. Printed in USA.
`
`(d
`
`Page 18 0f21
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`

`

`How to use GYNE-LOTRIMIN 3 Vaginal Cream with 3 disposable
`
`applicators.
`
`Directions ‘for Use
`
`Use the cream at bedtime for 3 days in a row.
`Read the full directions below before using.
`
`1. To open the tube, unscrew the cap. Press the sharp point of the cap into the sealed
`end of the tube. Push down firmly until the seal is broken. (See picture.)
`
`{2 pictures:
`
`v 2 hands unscrewing the cap from a tube of cream
`a 2 hands used to break the seal at the end of the tube}
`
`2. Attach the applicator to the tube of cream by placing end of the applicator firmly onto
`tube of cream. (See picture.)
`
`{picture showing the applicator being firmly attached to the tube}
`
`3. Gently squeeze the cream into the applicator, continue squeezing until line on
`plunger marked “FULL” reaches end of barrel. Separate the applicator from the tube.
`After each use, replace cap and roll up the tube from the bottom.
`
`{picture showing the applicator being filled by squeezing the tube from the
`bottom. Label the plunger as "plunger" and the barrel as "barrel."}
`
`4. Hold the barrel as shown in the picture.
`
`{picture with a hand holding the barrel}
`
`5. The Gyne-Lotrimin 3 Vaginal Cream applicator is inserted into the vagina in much the
`same way as a tampon. Gently insert the applicator into the vagina as far back as it will
`go comfortably. This can be done while lying on your back with your knees bent (as
`shown in the picture), or while standing with your feet apart and your knees bent.
`
`{picture showing recumbent position. Show frontal View of the human anatomy: vagina
`and urinary opening. Side view would show vagina, urinary opening, and rectum and
`where the applicator would be inserted. Use the symbol "a" (the international sign for
`do not enter) to indicate that the applicator should not be inserted in the urinary opening
`and rectum}
`
`6. With one hand holding the barrel, use the other hand to push the plunger into the
`barrel as far as it will go. Remove the applicator from the vagina.
`
`Page 19 0f21
`
`

`

`7. Throw the applicator away after each use. Do not flush it down the toilet.
`
`8. Lie down as soon as possible to keep the cream from leaking out.
`
`9. Repeat steps 2 through 8 with a new applicator before bedtime for the next 2 days.
`
`To protect your clothing from leakage or discharge, you may want to use deodorant-free
`pads or parity shields while you are using Gyne—Lotrimin 3 Vaginal Cream. Do not use
`tampons, douches. or spermicides until after you have completed the treatment and
`your symptoms are gone.
`'
`
`Page 20 of 21
`
`

`

`Attachment D:
`
`‘
`
`Tube
`
`Vaginal Cream
`
`3—Day Treatment
`
`Gyne-Lotrlmin 3 "
`Clotrirnazole Vaginal Cream (2%)
`Vaginal Antifungal
`
`Net Weight 219 (0.74 02.)
`
`For vaginal use only. Do not use in eyes or take by mouth ‘
`
`If this is the first time you have had vaginal itching and discomfort, consult your
`doctor.
`If you have had a doctor diagnose a vaginal yeast infection before and have
`the same symptoms now, use this cream as directed for 3 days in a row.
`
`Warnings: Read the Warnings and Directions on the carton and-in the
`educational brochure before using this product.
`
`Directions: To Open: Use cap to puncture seal.
`the vagina at bedtime for 3 days in a row.
`
`Insert one applicator of cream into
`
`Active lngredient: Clotrimazole 2% (100 mg per applicatOr).
`
`Store at room temperature 15° - 30°C (59° - 86°F). Avoid heat over 30°C or 86°F.
`See end of tube for lot number and expiration date.
`
`If the seal has been
`Safety Sealed: The tube opening should be sealed.
`punctured or the embossed design SP is not visible, do not use the product.
`
`© 1998 Distributed by Schering-Plough HealthCare Products. Inc.
`Memphis. TN 38151 USA. All Rights Reserved. Made in USA
`
`Page 210f21
`
`TUTQL P.27
`
`