. ALREXTM
`
`Ioteprednol etabonate
`ophthalmic suspension, 0.2%
`
`STERILE OPHTHALMIC SUSPENSION
`
`DESCRIPTION:
`ALREXTM (Ioteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-
`inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white
`powder.
`
`Loteprednol etabonate is represented by the following structural formula:
`
`76"?“
`- o.
`-
`.-
`'
`
`"'°°92°2"'s
`
`024H31CIO7
`
`'
`
`,
`
`_
`
`\
`
`MOI. Wt. 466.96
`
`Chemical name:
`Chioromethyl 17a—[(ethoxycarbonyl)oxy]-1 1 B—hydroxy-3—oxoandrosta-1 ,4-diene-17B-carboxylate.
`
`Each mL contains: ACTIVE: Loteprednol Etabonate 2 mg (0.2%);
`lNACTlVES: Edetate Disodium, Glycerin, Povidone, Purified Water, and Tyloxapol. Hydrochloric
`Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3 - 5.6. The suspension is
`essentially isotonic with a tonicity of 250 to 310 mOsmol/kg.
`PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
`
`CLINICAL PHARMACOLOGY:
`Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably
`delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte
`migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar
`formation associated with inflammation. There is no generally accepted explanation for the
`mechanism of action of ocular corticosteroids. However, corticosteroids are thought to
`It is
`act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins.
`postulated that these preteins control the biosynthesis of potent mediators of inflammation such
`as prostaglandins and leukotrienes by inhibiting the release of their common precursor
`'
`arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase
`A2. Corticosteroids are capable of producing a rise in intraocular pressure.
`
`Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20
`position ketone group is absent.
`It is highly lipid soluble which enhances its penetration into
`cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-
`related compounds so that it will undergo a predictable transformation to an inactive metabolite.
`Based upon in vivo and in vitro preclinical metabolism studies, Ioteprednol etabonate undergoes
`
`\\BLPLM1\VOL2\RA\7114\LEA\353|NSmar98.rtf
`Revised: 03/06/98
`
`Page 1 of 5
`
`
`
`Innopharma EX1039, Page 1
`
`Innopharma EX1039, Page 1
`
`

`

`extensive metabolism to inactive carboxylic acid metabolites.
`
`Results from a bioavailability study in normal volunteers established that plasma levels of
`loteprednol etabonate and A‘ cortienic acid etabonate (PJ 91), its primary, inactive metabolite,
`were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained
`following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate 8
`times daily for 2 days or 4 times daily for 42 days. This study suggests that limited
`(<1 ng/ml) systemic absorption occurs with ALREX.
`
`Clinical Studies:
`In two double-masked, placebo-controlled six-week environmental studies of 268 patients with
`seasonal allergic conjunctivitis, ALREX, when dosed four times per day was superior to placebo
`in the treatment of the signs and symptoms of seasonal allergic conjunctivitis. ALREX provided
`reduction in bulbar conjunctival injection and itching, beginning approximately 2 hours after
`instillation of the first dose and throughout the first 14 days of treatment.
`
`INDICATIONS AND USAGE:
`ALREXTM Ophthalmic Suspension is indicated for the temporary relief of the signs and
`symptoms of seasonal allergic conjunctivitis.
`
`CONTRAINDICATIONS:
`ALREX, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the
`cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia,
`and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular
`structures. ALREX is also contraindicated in individuals with known or suspected
`hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
`
`WARNINGS:
`Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects
`in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids
`should be used with caution in the presence of glaucoma.
`
`Prolonged use of corticosteroids may suppress the host response and thus increase the hazard
`of secondary ocular infections.
`In those diseases causing thinning of the cornea or sclera,
`perforations have been known to occur with the use of topical steroids.
`In acute purulent
`conditions of the eye, steroids may mask infection or enhance existing infection.
`
`Use of ocular steroids may prolong the course and may exacerbate the severity of many viral
`infections of the eye (including herpes simplex). Employment of a corticosteroid medication in
`the treatment of patients with a history of herpes simplex requires great caution.
`
`4
`_
`PRECAUTIONS:
`General: For ophthalmic use only. The initial prescription and renewal of the medication order
`beyond 14 days should be made by a physician only after examination of the patient with the aid
`of magnification, such as slit lamp biomicroscopy and, where appropriate, fiuorescein staining.
`
`If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
`
`If this product is used for 10 days or longer, intraocular pressure should be monitored.
`
`Fungal infections of the cornea are particularly prone to develop coincidentally with long-term
`
`\\BLPLM1\VOL2\RA\7114\LEA\353|NSmar98.rtf
`Revised: 03/06/98
`
`Page 2 of 5
`
`“mun—#7.
`
`Innopharma EX1039, Page 2
`
`Innopharma EX1039, Page 2
`
`

`

`03/09/98 MON 18:44 FAX 813 975 7757
`
`BLP REGULATORY
`
`“51 ""4
`
`lnforrnation for Patients: This product is sterile when packaged. Patients should be advised
`not to allow the dropper tip to touch any surface. as this may contaminate the suspension.
`if
`redness or itching becomes aggravated, the patient should be advised to consult a physician.
`
`eyes are not red, should be instructed to wait at least ten minutes after instilling ALREX before
`they insert their contact lenses.
`
`Carcinogenesis. mulagenesis, impairment of fertility: Long-tenn animal studies have not
`been conducted to evaluate the carcinogenic potential of lotepreanI etabonate. Loteprednol
`
`mglkglday of loteprednol etabonate, respectively, (1500 and 750 times the maximum clinical
`dose, respectively) prior to and during mating did not impair fertility in either gender.
`
`Pregnancy: Teratogenic effects: Pregnancy Category C. Loteprednol etabonate has been
`shown to be embryoto'xic (delayed ossification) and teratogenic (increased incidence of
`meningocele, abnormal left common carotid artery. and limb flexures) when administered orally
`to rabbits during organogenesis at a dose of 3 mglkglday (85 times the maximum daily clinical
`dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for
`these effects was 0.5 mglkglday (15 times the maximumdaily clinical dose). Oral treatment of
`rats during organogenesis with 0.5 to 100 mglkglday resulted in embryotoxicity (increased post-
`implantation losses at 100 mglkglday, and decreased fetal body weight and skeletal ossification
`with 250 mglkglday) and teratogenicity (absent innominate artery at 25 mglkglday doses, and
`cleft palate and umbilical hernia at 250 mglkglday). Loteprednol etabonate was maternally toxic
`(significantly reduced body weight gain during treatment) when administered to pregnant rats
`during organogenesis at doses of 25 mglkglday.
`
`Oral exposure of female rats to 50 mglkglday of loteprednol etabonate from‘the start of the fetal
`period through the end of lactation. a maternally toxic treatment regimen (significantly
`decreased body weight gain), gave rise to decreased growth and survival, and retarded
`development in the offspring during lactation; the NOEL for these effects was 5 mglkglday.
`Loteprednol etabonate had no effect on the duration of gestation or parturition when
`administered orally to‘pregnant rats at doses up to 50 mglkglday during the fetal period.
`
`Nursing Mothers: It is not known whether topical ophthalmic administration of corticosteroids
`could result in sufficient systemic absorption to produce detectable quantities in human milk.
`Systemic steroids appear in human milk and could suppress growth, interfere with endogenous
`corticosteroid production, or cause other untoward effects. Caution should be exercised when
`ALREX is administered to a nursing woman.
`
`Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
`
`H:\RA\711K\LEA\353iNSmar98.rtf
`Revised: 03/09/98
`
`Page 3 of 5
`
`Innopharma EX1039, Page 3
`
`Innopharma EX1039, Page 3
`
`

`

`ADVERSE REACTIONS:
`Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may
`be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular
`cataract formation, secondary ocular infection from pathogens including herpes simplex, and
`perforation of the globe where there is thinning of the cornea or sclera.
`
`Ocular adverse reactions occurring in 5—15% of patients treated with Ioteprednol etabonate
`ophthalmic suspension (0.2% - 0.5%) in clinical studies included abnormal vision/blurn‘ng,
`burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching,
`injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients
`include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular
`irntation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the
`underlying ocular disease being studied.
`
`Non-ocular adverse reactions occurred in less than 15% of patients. These include headache,
`rhinitis and pharyngitis.
`
`In a summation of controlled, randomized studies of individuals treated for 28 days or longer
`with Ioteprednol etabonate, the incidence of significant elevation of intraocular pressure (2 10
`mm Hg) was 2% (15/901) among patients receiving Ioteprednol etabonate, 7% (11/164) among
`patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.
`Among the smaller group of patients who were studied with ALREX, the incidence of clinically
`significant increases in IOP (210 mm Hg) was 1% (1/133) with ALREX and 1% (1/135) with
`placebo.
`
`DOSAGE AND ADMINISTRATION:
`SHAKE VIGOROUSLY BEFORE USING.
`One drop instilled into the affected eye(s) four times daily.
`
`HOW SUPPLIED:
`
`ALREXTM (Ioteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle
`with a controlled drop tip in the following sizes:
`2.5_mL bottle (NDC 24208-353-25) - AB35304
`5 mL bottle (NDC 24208-353-05) - A835307
`10 mL bottle (NDC 24208-353—10)- AB35309
`
`DO NOT USE IF NECKBAND IMPRINTED WITH “Protective Seal” and
`yellow (mortar and pestle graphic) IS NOT INTACT.
`
`Storage: Store upright between 15° - 25°C (59° - 77°F). DO NOT FREEZE.
`
`KEEP OUT OF REACH OF CHILDREN.
`
`Rx only
`
`Manufactured by:
`Bausch & Lomb Pharmaceuticals, Inc., Tampa, Florida 33637
`under Agreement with Pharrnos Corporation.
`US. Patent No. 4,996,335
`US. Patent No. 5,540,930
`
`\\BLPLM1\VOL2\RA\7114\LEA\353INSma198.rtf
`Revised: 03/06/98
`
`Page 4 of 5
`
`
`
`Innopharma EX1039, Page 4
`
`Innopharma EX1039, Page 4
`
`

`

`©Bausch & Lomb Pharmaceuticals, Inc.
`
`X050331 (Folded) Rev. 3/98—80
`XM10033 (Flat)
`
`\\BLPLM1\VOL2\RA\7114\LEA\353|NSmar98.rtf
`Revised: 03/06/98
`
`Page 5 of 5
`
`Innopharma EX1039, Page 5
`
`Innopharma EX1039, Page 5
`
`

`

`2/1 (/71?
`
`
`
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`
`;
`
`CORE 35395 LABEL
`4/0: PMS 197, PMS 294. (Nan, Black
`DIMENSIONS: 3 1/8" x 0.8125"
`3/4" unvarnisn area at left
`L-1605
`ART IS AT 100%
`PHARMACODH
`
`
`
`Innopharma EX1039, Page 6
`
`Innopharma EX1039, Page 6
`
`

`

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`
`CORE 35304 LABEL
`4/C: PMS 197. PMS 294, Cyan, Black
`DIMENSIONS: 3 1/8" x 0.8125"
`3/4" unvarnish area at Iefl
`L-1605
`ART IS AT 100%
`PHARMACODE#
`
`
`
`Innopharma EX1039, Page 7
`
`Innopharma EX1039, Page 7
`
`

`

`2 m vacuum
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`CORE 35307 LABEL
`4/0: PMS 197, PMS 294, Cyan. Black
`DIMENSIONS: 31/8"x 0.8125"
`3/4" unvarnish area at ieft
`L-1605
`ART IS AT 100%
`PHARMACODE#
`
`Innopharma EX1039, Page 8
`
`Innopharma EX1039, Page 8
`
`

`

`.'
`
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`
`Innopharma EX1039, Page 9
`
`rA
`
`CORE 35309 LABEL
`4/C: PMS 197. PMS 294. Cyan, Black
`DIMENSIONS: 3 3/8" x 0.711"
`5/8" unvamish area at left
`L-1614
`ART IS AT 100%
`PHARMACODE#
`
`MISC"
`>lLOMB
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`
`Innopharma EX1039, Page 9
`
`

`

`W3 lamdefl
`XGJIV
`
`
`eerie
`l
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`NDC 24?“? 353 51
`I '("fex
`loopedid emulate
`gnu-canine“; 7%
`
`dsns Malinda Bums
`703'0MsW
`
`EACH mL CONTAINS:
`ACTIVE:
`Loteprednol Etabonate
`2 mg (02%):
`INACTIVES.
`Glycerin, Povidone, Tyloxapol,
`Edetate Disodium and Purified Water
`Hydrodiloric Acid and/or Sodium
`Hydroxide may be added to adjust the
`pH to 5.3-5.6. The suspension is
`essentially isotonic with a tonicny of
`250 to 310 mOsmol/kg.
`PRESERVATIVE ADDED:
`Benzalkonium Chloride 0.01%.
`USUAI. DOSAGE:
`See Package insert.
`SHAKE VIGOROUSLV
`BEFORE USING.
`
`
`
`
`
`FOB OPHTHALMIC
`USE ONLY.
`
`KEEP OUT OF
`REACH OF
`CHILDREN.
`
`Storage:
`Store upright
`between
`15°-25°C (59°-77°Fl,
`DO NOT FREEZE.
`
`DO NOT USE
`IF NECKBAND
`iMPRlNTED WITH
`"Protective Seal"
`AND vmow i
`IS nor iNTACT.
`
`
`
`
`
`
`rqI x 1
`re ..
`i
`hteprednol etabonate
`
`Ophthalmic 3mm 0.2%
`
`‘
`
`gflttlgrl‘sw
`
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`
`i
`
`3
`
`‘
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`I
`
`Manufactured by
`Bausch 81 Lomb
`Pharmaceuticals, Inc:
`Tampa, Florida 33637 under
`Agreement With Pharmos Corporation.
`US. Patent No. 4,996,335
`Sterile
`US. Patent No. 5,540,930
`Ophthalmic
`Suspension
`‘
`© Bausch & tomb Pharmaceutmals, inc,
`
`
`
`
`Wu—NUI’ FOR RESALE
`
`
`
`Rx only
`
`'
`
`
`
`Entire carton is coated with varnish except bottom
`flap of carton.
`
`AB35395
`x096543
`H2/98-BB
`
`/
`
`,i’
`
`/
`
`CORE 35395
`4/C: PMS 197. PMS 294, Wan, Black
`DIMENSIONS: 1 5/8" X 1 1/16" x 3 3/8"
`L-2004
`ART IS AT 100%
`PHARMACODE#
`SCANNER BAR POSITION:
`
`
`
`Innopharma EX1039, Page 10
`
`Innopharma EX1039, Page 10
`
`

`

`
`
`uoisuadsns anuteqmdo sums
`968 0 mm mm
`
`_GIBU0q913 IOUDGJQSIII
`
`/
`
`EACH mL CONTAINS:
`ACTIVE:
`Loteprednol Etabonate
`2 "‘9 mm
`INACTIVES.
`Glycerin, Povrdone, Tyloxapol.
`Edelate Disodium and Purified Water.
`‘ HydrochloricAcid and/or Sodium
`gggfingggvgggg/fgh“WW
`
`Hydroxvde may be added to adjust the
`pH to 5.3-5.6. The suspenston is
`
`
`
`I
`
`
`
`
`
`.__I'/_ __ —H—---
`
`
`
`.
`
`FOR OPHTHALMIC
`USE ONLY.
`
`KEEP our 0F
`REACH OF
`CHILDREN
`
`Storage:
`Store upright
`
`between
`
`15°—25°c (59°—77°F),
`DO NOT FREEZE
`
`DO NOT USE
`IMPRINTED WITH
`IF NECKBAND
`"Protective Seal"
`AND YELLOW i
`IS NOT INTACT.
`
`RX 0""
`
`v
`BAL‘ SCH
`& LOMB =
`MC 24m: x, I“
`”
`'
`
`‘
`Ioieprednol etabonate
`
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`
`human elaborate
`mommy: 2%
`
`Slei ile
`Ophthalmic
`Suspenswn
`
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`
`.
`
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`i
`
`PRESERVATNE ADDED
`I Benzalkonium Chloride 0.01 %.
`, usum DOSAGE:
`See Package Insert.
`SHAKE weonousur
`BEFORE USING.
`Manufactured by
`Bausch 8. Lomb
`Pharmaceuticals, Inc.
`Tampa, Florida 33637 under
`2'5 “L
`Agreement with Pharmos Corporation,
`Sterile
`* US. Patent No 4,996,335
`Ophthalmic
`US Patent No. 5,540,930
`Suspension
`© Bausch & Lamb Pharmaceuticals, Inc
`
`
`
`
`
`
`\
`I
`
`Entire canon is coated with varnish except bottom
`flap of carton.
`
`AB35304
`X096544
`Hzrsaae
`
`I/
`
`CORE 35304
`4/0: PMS 197, PMS 294, Cyan, Black
`DIMENSIONS: 1 5/8" X1 1/16" x 3 3/8"
`L-2004
`ART IS AT 100%
`PHARMACODE#
`SCANNER BAR POSITION:
`
`
`
`Innopharma EX1039, Page 11
`
`Innopharma EX1039, Page 11
`
`

`

`
`
`mwdsnsawietiwdo Bums
`9530We mm
`
`W WWW
`X31":
`
`EACH ml. CONTAINS:
`ACTIVE:
`Loteprednol Etabonate
`2 mg (0.2%l;
`INACTIVES:
`Glycerin, Povrdone, Tyloxapol,
`Edetate Disodium and Purified Water,
`Hydrochloric Acid and/or Sodium
`Hydroxide may be added to adjust the
`pH to 5.3-5.6. The suspension is
`essentially isotonic with a tonicrty of
`250 to 3!) WWWkg
`PRESERVATIVE ADDED
`Benzalkonium Chloride 0.01%.
`USUAL DOSAGE:
`See Package Insert.
`SHAKE VIGOROUSLY
`BEFORE USING.
`
`
`
`
`
`
`
`Manufactured by
`Bausch 81 Lamb
`Pharmaceuticals, Inc
`Tampa, Florida 33637 under
`5 "L
`Agreement with Pharmos Corporation
`US. Patent No. 4,996,335
`Sterile
`US. Patent No, 5,540,930
`Ophthalmic
`Suspensron
`© Bausch & Lamb Pharmaceuticals, Inc.
`
`
`
`AB353U7
`
`xosssaz
`
`
`R2/98~88
`
`
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`
`BAUSCH
`& LOMB ”
`NDC 242%: 353705
`
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`Ioteprednol etabonate
`
`malmicamerism02%
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`Sterile
`Ophthalmic
`Suspension
`
`
`
`/
`
`/
`
`ran OPHTHALMIC
`us: ONLY.
`
`KEEP OUT OF
`REACH OF
`CHILDREN.
`
`Storage:
`Store upright
`
`tsetvgeg(59
`
`77 H
`
`°‘ °-
`°
`°'
`DO NOT FREEZE,
`
`I
`;
`
`DO NOT USE
`
`rr NECKBAND
`
`IMPRINTED WITH
`
`“Protective Seal"
`
`AND YELLOW i
`IS NOT INTACT.
`
`I
`
`Rx only
`
`Entire carton is coated with varnish except bottom
`flap of carton.
`
`CORE 35307
`4/C: PMS 197, PMS 294, Cyan, Black
`DIMENSIONS: 1 5/8" x1 1/16" x 3 3/8"
`L-2004
`ART IS AT 100%
`PHARMACODEiI
`SCANNER BAR POSITION:
`
`
`
`Innopharma EX1039, Page 12
`
`Innopharma EX1039, Page 12
`
`

`

`”SI-“$78 WIWIWO aims
`
`Rommw
`
`EACH nil CONTAINS:
`AC TIVE:
`Loteprednol Etabonate
`2 mg (0.2%I;
`INACTIVES:
`Glycerin. Povidone, Tyloxapol,
`Edetate Disodrum and Purilred Water.
`Hydrodtlor ic Acid and/or Sodium
`Hydroxide may be added to adjust the
`pH to 5.3-5.6. The suspensron is
`essentially isotonic With a tonicity oi
`250 to 310 mOSmol/kg.
`PHESEHVATIVE ADDED:
`Benzalkonium Chloride 0.01%.
`USUAL DOSAGE:
`See Package Insert
`SHAKE VIGOROUSLY
`BEFORE USING.
`
`Manufactured by
`Bausch 8r Lomh
`Pharmaceuticals, Inc.
`Tampa, Florida 33637 under
`Agreement wrth Pharmos Corporation,
`US. Patent No. 4,996,335
`US. Patent No. 5,540,930
`© Bausch 8r Lamb Pharmaceuticals, Inc.
`
`
`
`Entire carton is coated with varnish except bottom
`flap of carton.
`
`CORE 35309
`4/0: PMS 197. PMS 294. (Nan. Black
`DIMENSIONS: 1 5/8" x1 1/16" x 3 3/8"
`L-2004
`ART IS AT 100%
`PHARMACODE#
`SCANNER BAR POSITION:
`
`
`
`I
`
`
`I
`i
`
`II
`
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`
`ophthalmic Won 0 2%
`
`DO nor USE
`IF NECKBAND
`IMPRINTED WITH
`“Protective Seal"
`AND YELLOW i
`IS NOT iNTACT.
`
`Rx only
`
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`
`
`
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`R 2/98-88
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`
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`
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`eieuoqele IOUDQJGGIOI
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`FOR OPHTHALMIC
`BAUSCH
`USE ONLY.
`& LOMB‘
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`I
`hieprednol etabonate
`I
`
`KEEP OUT OF
`REACH OF
`CHILDREN.
`
`Storage:
`Store upright
`
`belween
`
`15°—25°c (59°—77°Fi,
`DO NOT FREEZE.
`
`
`
`Innopharma EX1039, Page 13
`
`Innopharma EX1039, Page 13
`
`