FDA.reportPublic FDA data

Clear Eyes Triple Relief

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:32:25

Label at a glance#

ProductClear Eyes Triple Relief
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

for the temporary relief of burning & irritation due to dryness of the eye for use as a protectant against further irritation or to relieve dryness of the eye relieves redness of the eye due to minor eye irritations

Dosage and administration

Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl alcohol 0.5%

Purpose

OTC - PURPOSE SECTION

Lubricant

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Povidone 0.6%

Purpose

OTC - PURPOSE SECTION

Lubricant

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning & irritation due to dryness of the eye
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • relieves redness of the eye due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only.

Do not use if

OTC - DO NOT USE SECTION

solution changes color or becomes cloudy.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma.

When using this product

OTC - WHEN USING SECTION

  • to avoid contamination, do not touch tip to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become temporarily enlarged

Stop use & ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens or symptoms last 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Other information

OTHER SAFETY INFORMATION

  • store at room temperature
  • remove contact lenses before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dextrose, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate

Questions?

1-877-274-1787 Cleareyes.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


CLEAR EYES®

TRIPLE RELIEF 
LUBRICANT/REDNESS RELIEVER EYE DROPS

STERILE 0.5 FL OZ (15 mL)

CLEAR EYES® TRIPLE RELIEF LUBRICANT/REDNESS RELIEVER EYE DROPS STERILE 0.5 FL OZ (15 mL)CLEAR EYES® TRIPLE RELIEF LUBRICANT/REDNESS RELIEVER EYE DROPS STERILE 0.5 FL OZ (15 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1235569polyvinyl alcohol 0.5 % / povidone 0.6 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN9
1235569polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD9
1235569polyvinyl alcohol 0.5 % / povidone 0.6 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-898-01Clear Eyes Triple Relief1 in 1 BOXLIQUID19
67172-898-01Clear Eyes Triple Relief15 mL in 1 BOTTLE, DROPPERLIQUID159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-898CLEAR EYES TRIPLE RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]9Current NDC, Legacy NDC, 2 package rows20241102_1269a1a6-843d-4d08-bb3c-c1f3d2e7080d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYVINYL ALCOHOLACTIVE INGREDIENT532B59J9901
POVIDONEACTIVE INGREDIENTFZ989GH94E1
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7D1
POLYVINYL ALCOHOLACTIVE MOIETY532B59J9901
POVIDONEACTIVE MOIETYFZ989GH94E1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y0771
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W21
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I101
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA741
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SW1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67172-89867172-898-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990ACTIB
POVIDONEFZ989GH94EACTIB
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSEIY9XDZ35W2IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 190 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DEXTROSEDEXTROSEIY9XDZ35W2SOLUTION / INTRAVENOUS5.05 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3219 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVITREAL0.18 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRASPINAL75 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
68 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRAVENOUS51.7 mgExact identifier — unii candidate
42 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2PASTILLE / ORAL826 mgExact identifier — unii candidate
42 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
68 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii candidate
42 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRAVENOUS51.7 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
68 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, CHEWABLE / ORAL1286 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
68 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+route
6 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / OPHTHALMIC0.22 %w/vExact identifier — unii+route
6 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TROCHE / ORAL903.5 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, SUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii+route
20 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAVENOUS161 mgExact identifier — unii candidate
18 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii+dosage form
12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAVENOUS161 mgExact identifier — unii candidate
18 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRATHECAL1925 mgExact identifier — unii candidate
42 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii+route
20 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii+route
22 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SUSPENSION / OPHTHALMIC0.03 %w/wExact identifier — unii+route
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii+route
20 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii+route
22 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
68 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii+route
20 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii+dosage form
12 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii+dosage form
22 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii+dosage form
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route
20 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2POWDER / VAGINAL430 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAMUSCULAR161 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAMUSCULAR175 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
68 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii+route
22 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSOLUTION / ORAL25 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii+route
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii+route
20 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii+route
22 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
68 equally ranked IID candidates

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
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
ndc (package): 67172-898-01
ndc (product): 67172-898
ndc11 (package): 67172089801
spl id: 1c1f47ce-b2f8-4ee8-b431-e1918f238f7f
spl set id: 1269a1a6-843d-4d08-bb3c-c1f3d2e7080d

Reported adverse events (FAERS/openFDA)#

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