Polyvinyl Alcohol Solution/ Drops
FDA Label NDC 50268-678

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 Polyvinyl Alcohol (NDC 50268-678). 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 active ingredient, purpose, uses, warnings, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

Uses

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

Warnings

  • 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

    • 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

Keep Out Of 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 to 2 drops in the affected eye(s) as needed

Other Information

  • Store at room temperature 15-30C (59-86C)
  • Do No 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

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Questions ?

Call 1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

Package/Label Principal Display Panel

15 (678 15)

15 (678 15)

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