FDA.reportPublic FDA data

Stye Eye Drops 63029-324

Manufacturer
Medtech Products Inc.
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:40:12

Label at a glance#

ProductStye
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE
Label structure10 sections

Indications and uses

For temporary relief of discomfort due to minor irritations including: burning, stinging, itching.

Dosage and administration

instill 1 to 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl alcohol 0.5%
Povidone 0.6%

Purpose

OTC - PURPOSE SECTION

Lubricant
Lubricant

Uses

INDICATIONS & USAGE SECTION

For temporary relief of discomfort due to minor irritations including: burning, stinging, itching.

Warnings

WARNINGS SECTION

for external use only

Do not use

OTC - DO NOT USE SECTION

if solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • to avoid contamination, do not touch tip to any surface
  • replace cap after using

Stop use and 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 persists 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) as needed

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?

OTC - QUESTIONS SECTION

1-800-344-7239

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stye ™

LUBRICANT EYE DROPS

STERILE       0.5 fl oz (15 mL)

PRINCIPAL DISPLAY PANEL Stye ™ LUBRICANT EYE DROPS STERILE 0.5 fl oz (15 mL)PRINCIPAL DISPLAY PANEL Stye ™ LUBRICANT EYE DROPS STERILE 0.5 fl oz (15 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionPSN3
2586181Stye Soothing Relief 0.5 % / 0.6 % Ophthalmic SolutionPSN3
2586181polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic Solution [Stye Soothing Relief]SBD3
598050polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCD3
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionSY3
2586181Stye Soothing Relief (polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML) Ophthalmic SolutionSY3
2586181Stye Soothing Relief (polyvinyl alcohol 0.5 % / povidone 0.6 % ) Ophthalmic SolutionSY3

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
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
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
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct 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
63029-324-15Stye1 in 1 BOTTLESOLUTION/ DROPS13
63029-324-15Stye15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-32463029-324-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-25full-release2026-06-01 00:32:14

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
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
ndc (package): 63029-324-15
ndc (product): 63029-324
ndc11 (package): 63029032415
spl id: 30207af5-e43e-4ac0-a76c-4824f020e24c
spl set id: 60c11d3d-df20-4d1c-b425-49a84fecea30

Reported adverse events (FAERS/openFDA)#

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