Artificial Tears Solution/ Drops
FDA Label NDC 50268-043

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 Artificial Tears (NDC 50268-043). 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, 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
Dextran 70 0.1%Lubricant
Glycerin 0.2%Lubricant
Hypromellose 0.3%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

For use in the eyes only

Do Not Use

  • if this 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 any of the following:

  • You experience eye pain, changes in vision, continued redness and 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 or 2 drops in the affected eye(s) as needed

Other Information

  • store at room temperature

Inactive Ingredients:

benzalkonium chloride, boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

Questions?

1-855-361-3993

Distributed by:
AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

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