Lubricant Eye Drops Solution

Manufacturer
AvPAK
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:37:06

Label at a glance#

ProductLubricant Eye Drops Solution
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure12 sections

Indications and uses

For the temporary relief of burning, irritation and discomfort due to dryness of the eye and exposure to wind or sun. May be used as a protectant against further irritation.

Dosage and administration

shake well before use instill 1 or 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye and exposure to wind or sun.
  • May be used as a protectant against further irritation.

Warnings

WARNINGS SECTION

For use in the eyes only

Do not use

OTC - DO NOT USE SECTION

  • If solution changes color or becomes cloudy.

When using this product

OTC - WHEN USING SECTION

  • avoid contamination, do not touch tip of container to any surface
  • replace cap after use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • the condition worsens or persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • instill 1 or 2 drops in the affected eye(s) as needed

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature 15°- 30°C (59°-86°F).
  • do not use if imprinted seal on cap is torn, broken or missing
  • discard 90 days after opening
  • retain outer carton for full product information

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Benzalkonium chloride (preservative), boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

OTC - QUESTIONS SECTION

1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1515

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN4
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD4
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-126-15Lubricant Eye Drops Solution1 in 1 CARTONSOLUTION14
50268-126-15Lubricant Eye Drops Solution15 mL in 1 BOTTLESOLUTION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-126-15ML - Milliliter50268-1265d07032c-3ebe-462b-bcbf-d98ebd4c8f2012023-04-07

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50268-12650268-126-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
ndc (package): 50268-126-15
ndc (product): 50268-126
ndc11 (package): 50268012615
spl id: 47e233a3-ffe7-6bf0-e063-6394a90a5b55
spl set id: f5743b38-e3d2-a065-e053-2995a90a4b9a

Reported adverse events (FAERS/openFDA)#

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