• 0 0000 0000 00 0
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Jock Itch
`Product
`6g Tube
`
`8
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 1 of 8
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1519
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Jock Itch
`Product
`6g Tube
`
`8
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 1 of 8
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1519
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`
`
`--'
`
`-
`
`-
`
`··-
`
`-
`
`-
`
`• children under 12-years: ask .. a doator
`• wash 'hands after each J:lse
`for ·1 week ·or as.dfteete.d by a doctor.
`··~pply once-ad~~ (~·ofn·ing-·or night)
`and dry compfetelyb'efore applying
`• wash ttle.affetted.sRinwith··soap and water
`tlle ·tdoe, ·
`• u~ the tip ofthe cap to b'reak tfm s~ and open
`
`· ·
`
`• a~ults fWd'chii(Jren 12. Y$1~ and alder
`DirecJions
`rigbtaway.·
`mediCal help·:orcontacta.poisorn:ontrol tenter
`eep out of reach of· chUilre.n. If swallowed~ get
`~curs b.rge.ts w.o~.
`
`.K
`
`Stop use and aslfa.doctar rHoo muth irritatlbn
`eye wnla{)toccur$~ iinse thoroughlY \vith wate't
`When ,using: H1isipro~u&t do.not getin~to eyes. If(cid:173)
`• .for·v®;n~ y~ast infections
`• in or near th.e ni'outh .or the .eyes
`Do not use ·• on nails or S@.IP
`For externa.l use only
`wa·mings'
`which accompany this-condition
`• reJieyes itching, bur~lng. cracking. and scaHno
`Uses • cures mfi.st:joc~ itch' (tinm cruris}
`Tetoinafi~e l% .................. ;-............. ·~· ......... Antifungal
`Pu1,pose
`~01/~e IITi/IBif.l~m
`
`&
`: ©,2'006-Mad.e' ln Ge~many
`
`Novarlts Cilni\tmer Heaflbt lm:.
`
`See: C (fffitl, t-or. lot fl.Uinber. and Mr.r.iMtft.,n
`Store at orbelow·30°C .(860JF)
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Jock Itch
`Product
`
`6g Tube - Enlarged 300%
`
`10
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 2 of 8
`
`
`
`Directions
`• adults and children 12 years and over
`• use lhe tip of lhe cap to break lhe seal and open the tube
`• wash lhe affected skin wnh soap and waler and dry completely before applying
`• for alhlate's foot between the toes: apply once a day at bedtime
`for 1 week or as direcled by a doctor. Wear well-fitting, ventilaled
`shoes. Change shoes and socks at leasl once daily.
`• for jock Itch and ringworm: apply once a day (morning or night)
`for 1 week or as direcled by a doctor.
`• wash hands after each use
`• children under 12 years: ask a doctor
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Athlete's Foot
`Product
`6g Pillow Pack
`
`2
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 3 of 8
`
`
`
`...,.
`
`>,
`
`~I • ~hildrM u(lder 12 years:. ask a doctor
`
`• wash hands after each use
`n~ht) for'1 week or as diTected by a doctor.
`• tor jocj( itch and ringworm: app~.once a day (morning or
`ventilated sOOes. Change shoes and socks at leas! o~ dai~.
`bed~me for 1 week or as diretted by a doctor: Wear weD·ftt1in~
`• for athlete1S foot between the toes: app~ QllOO a day at
`comptele~ before appf;'ing
`• wash llle affected skin with soap and waler and dry
`.. use the lip of the cap 'to break the seal and open \he lube
`•adul'ts.an~ chilaren 12 years al)(i over
`· ··
`Directions,
`·· ·
`oof$.cta poi$pn control c:en!er r~ht·away.
`Keep out of ~aoh of children. If swal&lwed1 get meafcal help o;
`worse.
`Stop use and ask a doctor it too much irrlfation ocwrs or gets
`
`----
`
`. contacl ~~rs, rinse toorov~h~ wi1fl water.
`When using this produc.t do oot get into the eyes. If eye
`• tor vaginal yeast intdons
`t in or neat the mo u1fl·or lhe ey-es
`Do ~t use • on nails or scalp
`For external use on~
`wa_mi.ngs
`accompany these oondilioris
`• rei~~ ~ch~g, bumif)g,'cracklngl and scaling whtth
`{~a oorpoos}
`• .cures most Jock ttch {tinea cruris) ·and rfngworm
`EffedWeness on th'e oonorn otsides·:of· fo.ot is unknown.
`• cures ~t·alhlete~ foot (tinea·pedis) behVe¢ij \fie roes.
`Uses
`li rb' ali" ' ' 101.
`e lfl ~ f(J .. ,, .. u., .. .,, ..... ,,,, .......... ,,,,,u•••uuoou ... Hnttt41"\tfli!U ~
`Active i~gredlent
`
`A~rngal
`Purpose
`
`Parsippanv, r~J 07054-G622 ©2006 Made ln [~Dmm\ll
`Distributed by: Novartis Consumer Health~ Inc.
`
`-
`
`PillfJJI.Pi!IIJ.lAJhtJhlZZM%£.P.
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Athlete's Foot
`Product
`
`6g Tube - Enlarged 300%
`
`4
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 4 of 8
`
`
`
`• 0
`
`0
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Jock Itch
`Product
`12g Pillow Pack
`
`11
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 5 of 8
`
`
`
`• chtldren under 1'2 years:'"ask a doctor
`• wash hands after eath use
`as directed by a doctor.
`• apply once a day· (morning or ni.ght)'f0r l week or
`cornplete1y be·fore .applying
`• wash the affected skin with soap and water and dry
`• use-the tip,ofthe.cap.to break the sear-and open the tube
`• adults·.and t'i:hildren 1.2 years· and older
`Directions
`help or c.ontac.t a poison -control center right away.
`K~QP out·-or·re_ach. of ciiUd~ren.lf swallowed,,.get medical
`gets worse.
`Stop use a;nd ask a dnctor if'too much irritation occurs -or
`
`-
`
`Parsiooanv:.NJ 07054~0622. @:2006 Made in' r2nl"n'>""'
`DJstributed by; ~ovart}:s C.onsumer Health-, Inc.
`
`-""
`
`-~
`
`contactoccurs, rrnse.thorough.ly with water.
`When using Ibis ·pradu·ct do not ·g·et into eyes. ~f eye
`• for vaginal yeast infe.ctions
`• in or near-the mouth or the eyes
`Do not usf) •· on nails or scalp
`For external use only
`Warpings
`wh'ic h accom-pa·ny ·this ·condition
`• relieves .Uching, burning, cracking and ·scaring
`• cures most jock itch (tinea cruris)
`Usss
`Terbinafine; 1 6/c) •...•.•••..•••..•.....••.••• .-•. .,. ...••.•.••••••.••••• Antifuruial
`Purpose
`ctiVe .tngredienl
`
`.A
`
`See crrmo for lot number and nvni .. .-.+; .......
`Store .~t orbelow _30°G (86°F)
`
`,-.
`
`-
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Jock Itch
`Product
`12g Tube - Enlarged 300%
`
`13
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 6 of 8
`
`
`
`Directions
`• adults and children 12 years and over
`• use the tip of the cap to break the seal and open the tube
`• wash the affected skin with soap and water and dry completely before applying
`•lor athlete's foot between the toes: apply once a day at bedtime
`for 1 week or as directed by a doctor. Wear well-fitting, ventilated
`shoes. Change shoes and socks at least once daily.
`•lor Jock Itch and ringworm: apply once a day (morning or night)
`for 1 week or as directed by a doctor.
`• wash hands after each use
`• children under 12 years: ask a doctor
`
`UIWI
`Jmlllla
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Athlete's Foot
`Product
`12g Pillow Pack
`
`5
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 7 of 8
`
`
`
`"
`
`---------------·
`
`l
`
`Pu~e Stop ~se.and·ask a doctor it too much irritation occurs or gets worse.
`
`, tl !"~'~'I Ant-iftJngal
`
`.
`
`• wash hands after each use.
`riight) for 1-week or as.dire.ct~d by a doct'or.
`•-for jock itch and r[ngvionn: apply once.a ·day .(morning or
`ventilated shoes. Change. shoes a.nd so-cks at least once· daily.
`bedtinw for,1 week or as dir.epted by a. doctor. Wear well~titting,
`• for athlete's foot between the toes: apply ooce a d.ay at
`before applying
`• wash the affected· skin wfth ·soap and water and dry complete~
`• use··flR~·tip ef'tqe cap to break. the seal and.ope·~ ~e tube
`• adults and cnildre·n 12 years-and over
`liireclions
`ontact a poison cont~bl center right away~
`Keep out of reach of clllldren.l'f swallowed, get medical help or
`
`.c
`
`., 1 ,, children under ·12 years: ask a doctor
`
`occurs~ rinse thoroughly wifh water:
`When u~ing this product do nat get into the.ey_es.lfeye oontacl
`• for vaginal. y~a~t infections
`• in or h&ar the ·mouth orthe ey:es
`o not u:se-• on nails or scalp
`For external use only
`Warnings
`these conditions
`• reli(1ves.·Hchtng~ b~rning, craoking,·and sq_aling which aooompcmY
`• cures most joek':itcn (t{nea cruriS) and ringworm ,(Unea~oorpons) ·
`Effectiveness on th'e bottom or sides of foot is unKnown.
`'cures mostatntete~s.foot (tinea pedi$) between the toes.
`Uses
`elbi na.flhe 1'o/o ..... ll .... I I I I Ill 111111 .
`,Acfiveingiedient
`
`...... I I. I I I I. I. I. I ... I."" ••• I, I. I I I, I I I, ...
`
`---
`
`.
`
`'T
`
`.D
`
`Parsippany,.NJ 070.54::.062.2 .©2006 Made in qermany
`Distributed by: Novarlis Consumer Health, Inc ..
`
`See crimo for lorn umber and
`Store&~ or below 30°C (86°F)
`
`Novartis Consumer Health, Inc.
`NDA 21-958
`
`Confidential
`Athlete's Foot
`Product
`12g Tube - Enlarged 300%
`
`7
`Lamisil® (terbinafine) DermGel™, 1% Gel
`
`Page 8 of 8
`
`
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