throbber
8/15/22, 12:16 PM
`
`DailyMed - ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid
`
`LABEL: ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid
`
`VIEW PACKAGE PHOTOS
`
`NOC Code(~);_ 10742-8142-1
`Packager: The Mentholatum Company
`
`Category: HUMAN OTC DRUG LABEL
`DEA Schedule: None
`Marketing Status: OTC monograph final
`
`DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they
`comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
`
`DRUG LABEL INFORMATION
`If you are a consumer or patient please visit this yersjon.
`
`Updated October 4, 2021
`
`CLOSE ALL SECTIONS
`ACTIVE INGREDIENTS
`
`Naphazoline hydrochloride 0.012%
`
`Polysorbate 80 0.2%
`
`Wlli.
`
`PURPOSE
`
`Naphazoline hydrochloride - Redness reliever
`
`Polysorbate 80 - Lubricant
`
`USES
`
`relieves redness of the eye due to minor eye irritations
`temporarily relieves burning and irritation due to dryness of the eye
`.tlllli.
`
`https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=69166dec-fb86-4c76-9efe-88c3bb12a8f0
`
`1/5
`
`Eye Therapies Exhibit 2095, 1 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`8/15/22, 12:16 PM
`
`DailyMed - ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid
`
`WARNINGS
`
`For external use only
`
`Ask a doctor before use if you have
`narrow angle glaucoma
`
`When using this product
`do not touch tip of container to any surface to avoid contamination
`replace cap after each use
`do not use if solution changes color or becomes cloudy
`overuse may cause more eye redness
`pupils may become enlarged temporarily
`remove contact lenses before using
`
`Stop use and ask a doctor if
`you feel eye pain
`changes in vision occur
`redness or irritation of the eyes lasts
`condition worsens or lasts more than 72 hours
`
`Keep out of reach of children.
`If swallowed, get medical help or contact a Poison Control Center right away.
`
`CLDSE
`
`DIRECTIONS
`
`put 1 or 2 drops in the affected eye(s) up to 4 times daily
`
`tightly snap on cap to seal
`Other information
`
`do not store above 25°C (77°F)
`CLDSE
`
`INACTIVE INGREDIENTS
`
`alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified
`water, sodium borate
`
`CLOSE
`
`OUESTIONS?
`
`1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)
`
`PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
`
`https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=69166dec-fb86-4c76-9efe-88c3bb12a8f0
`
`2/5
`
`Eye Therapies Exhibit 2095, 2 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`8/15/22, 12:16 PM
`
`DailyMed - ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid
`
`111111111 11
`
`...-RoHro·
`coo.- en: 0ll!ON
`cool
`
`l)uff«u ......
`-------·-·-
`=~~-=
`... -(cid:173)
`;;..---·------;,.,.....
`. .. .... _
`....... -_,.,
`-
`-...-.-
`---__ ,,__,
`··---·-·---
`...,_.,.
`···-·-- --(cid:173)
`·-~--·-
`·(cid:173)•·--(cid:173).......
`-
`·-....... =••
`
`,,.,,._
`
`1.-
`
`...... .,, .....
`
`CLOSE
`
`INGREDIENTS ANO APPEARANCE
`
`ROHTO COOL
`naphazoline hydrochloride, polysorbate 80 liquid
`
`PRODUCT INFORMATION
`
`Product Type
`
`HUMAN OTC DRUG
`
`Route of Administration OPHTHALMIC
`
`Item Code (Source) I NDC:10742-8142
`
`ACTIVE INGREDIENT/ACTIVE MOIElY
`
`Ingredient Name
`
`Basis of Strength
`
`Strength
`
`NAPHAZOLINE HYDROCHLORIDE (UNII:
`MZ1131787D) (NAPHAZOLINE-
`UNll:H231GF11BV)
`
`POLYSORBATE 80 (UNII: 6OZP39ZG8H)
`(POLYSORBATE 80 - UNll:6OZP39ZG8H)
`
`NAPHAZOLINE
`HYDROCHLORIDE
`
`.12 mg
`in 1 ml
`
`POL YSORBATE 80
`
`2 mg in 1 ml
`
`https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=69166dec-fb86-4c76-9efe-88c3bb12a8f0
`
`3/5
`
`Eye Therapies Exhibit 2095, 3 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`8/15/22, 12:16 PM
`
`DailyMed - ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid
`
`Strength
`
`1 mg in 1 ml
`
`INACTIVE INGREDIENTS
`
`Ingredient Name
`
`ALCOHOL (UNII: 3K9958V90M)
`
`BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
`
`BORIC ACID (UNII: R57ZHV85D4)
`
`CHLOROBUTANOL (UNII: HM4YQM8WRC)
`
`EDETATE DISODIUM (UNII: 7FLD91 C86K)
`
`MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
`
`WATER (UNII: 059QF0KO0R)
`
`SODIUM BORATE (UNII: 91 MBZ8H3QO)
`
`PACKAGING
`
`#
`
`1
`
`1
`
`Item Code
`
`Package Description
`
`Marketing
`Start Date
`
`Marketing End
`Date
`
`NDC:10742-
`8142-1
`
`1 in 1 CARTON
`
`08/21 /2001
`
`13 ml in 1 BOTTLE, WITH
`APPLICATOR; Type 0: Not a
`Combination Product
`
`MARKETING INFORMATION
`
`Marketing
`Category
`
`Application Number or Monograph Marketing Start Marketing End
`Citation
`Date
`Date
`
`OTC monograph
`final
`
`part349
`
`08/21 /2001
`
`LABELER -THE MENTHOLATUM COMPANY (002105757)
`
`REGISTRANT-THE MENTHOLATUM COMPANY (002105757)
`
`ESTABLISHMEMT
`
`NAME
`
`ADDRESS
`
`ID/FEI
`
`BUSINESS OPERATIONS
`
`Rohto-Mentholatum (Vietnam) Co. Ltd.
`
`555347535 MANUFACTURE(10742- 8142)
`
`https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=69166dec-fb86-4c76-9efe-88c3bb12a8f0
`
`4/5
`
`Eye Therapies Exhibit 2095, 4 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`8/15/22, 12:16 PM
`
`DailyMed - ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid
`
`CLOSE ALL SECTIONS
`
`FIND ADDITIONAL RESOURCES (also available in the left menu)
`
`SAFETY
`
`ReRort Adverse Events, FDA SafetY. Recalls, Presence in Breast Milk
`
`RELATED RESOURCES
`
`Medline Plus, Clinical Trials, PubMed, Biochemical Data Summa[Y.
`
`MORE INFO ON THIS DRUG
`
`View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(~).NEW!
`
`D}NLM
`
`https://dailymed.nlm.nih.gov/dailymed/druglnfo.cfm?setid=69166dec-fb86-4c76-9efe-88c3bb12a8f0
`
`5/5
`
`Eye Therapies Exhibit 2095, 5 of 5
`Slayback v. Eye Therapies - IPR2022-00142
`
`

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