FDA.reportPublic FDA data

Clear Eyes

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2021-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:26:46

Label at a glance#

ProductClear Eyes Once Daily Eye Allergy Itch Relief
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

a dults and children 2 years of age and older:   • put 1 drop in the affected eye(s) once daily, no more than once per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • replace cap after each use c hildren under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Olopatadine (0.2%)
(equivalent to olopatadine hydrochloride 0.222%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

INDICATIONS & USAGE SECTION

temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Warnings

WARNINGS SECTION

For external use only

__________________________________________________________________________

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • do not wear a contact lens if your eye is red

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: 
    • put 1 drop in the affected eye(s) once daily, no more than once per day
    • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    • replace cap after each use
  • children under 2 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • only for use in the eye
  • store between 2° - 25°C (36° - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01% (preservative), dibasic sodium phosphate anhydrous, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride, and water for injection 

Questions?

OTC - QUESTIONS SECTION

1-877-274-11787 Cleareyes.com

TAMPER EVIDENT: For your protection, this bottle has a ring around the neck. Do not use if ring is separated from cap, damaged, or missing at time of purchase.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEAR EYES®

---- ONCE DAILY ----

EYE ALLERGY ITCH RELIEF

 

OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION USP, 0.2%
ANTIHISTAMINE

 

Sterile 2.5 mL (0.085 FL OZ)

PRINCIPAL DISPLAY PANEL CLEAR EYES® ---- ONCE DAILY ---- EYE ALLERGY ITCH RELIEF OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.2% ANTIHISTAMINE Sterile 2.5 mL (0.085 FL OZ)PRINCIPAL DISPLAY PANEL CLEAR EYES® ---- ONCE DAILY ---- EYE ALLERGY ITCH RELIEF OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.2% ANTIHISTAMINE Sterile 2.5 mL (0.085 FL OZ)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67172-50467172-504-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLOPATADINE HYDROCHLORIDE2XG66W44KFACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROCHLORIC ACIDQTT17582CBIACT
POVIDONEFZ989GH94EIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090848-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13c2088c7a36db…
2026-09-14 22:38:342026-08A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-1384e616aacf4f…
2026-08-18 06:07:402026-07A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2015-07-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2015-07-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2015-07-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2015-07-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2015-07-133f01610625f2…
2019-09-15 20:21 UTC2019-09A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2015-07-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2015-07-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090848-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2015-07-133a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090848-001AT174a2ff9319b5…
2021-03-12 10:30 UTC2021-03A090848-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090848-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090848-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090848-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A090848-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090848-001AT1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ee039a44-3d5a-4efe-b026-72cfb005c7149d4a6b1b-b872-45da-bcc9-8a5f8bd478ca2024-04-04WarningsExact identifier
spl set id: 9d4a6b1b-b872-45da-bcc9-8a5f8bd478ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.