Lubricant Eye Drops Solution
FDA Label NDC 50268-126

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avpak for the product Lubricant Eye Drops Solution (NDC 50268-126). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

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

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.

Warnings

For use in the eyes only

Do Not Use

  • If solution changes color or becomes cloudy.

When Using This Product

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

Otc - Stop Use

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

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

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

Other 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:

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?

1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

Principal Display Panel

15 (126 15)

15 (126 15)

* Please review the disclaimer below.