Freshkote Preservative Free Lubricant Eye Drops Solution
FDA Label NDC 71776-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eyevance Pharmaceuticals for the product Freshkote Preservative Free Lubricant Eye Drops (NDC 71776-001). 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 - active ingredient, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients            Purpose

Polyvinyl Alcohol 2.7%.........Lubricant

Povidone 2.0%....................Lubricant

Indications & Usage

Uses

  • For use as a lubricant to reduce further irritation or to relieve dryness of the eye

Warnings

Warnings

For external use only.

Otc - Do Not Use

Do not use if

  • Seal is damaged
  • Solution changes color or becomes cloudy
  • You are sensitive to any ingredient in this product

Otc - Stop Use

Stop use and ask a doctor if

  • You experience eye pain
  • You experience changes in vision
  • You experience continued redness or irritation
  • Condition worsens
  • Symptoms last more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

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

Dosage & Administration

Directions

Instill 1 or 2 drop(s) in the affected eye(s) as needed

Storage And Handling

Other information

  • Use before expiration date marked on container
  • Store at 20-25 οC(68-77 οF)
  • Retain this carton for future reference
  • Do not freeze

Inactive Ingredient

Inactive ingredients

Boric acid, Edetate disodium, Ethanol, Glycerin, Phospholipids, Polysorbate 80, Potassium chloride, Purified water, Sodium chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Otc - Purpose

Purpose

For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Otc - When Using

When using this product

  • Do not touch tip of container to any surface to avoid contamination
  • Replace cap after using
  • Shake off remaining drop before replacing cap

* Please review the disclaimer below.