Sunmark Lubricating Tears Solution/ Drops
FDA Label NDC 49348-149

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Sunmark Lubricating Tears (NDC 49348-149). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Polyethylene glycol 400 0.4%, Propylene glycol 0.3%

Purpose

Polyethylene glycol 400....Lubricant

Propylene glycol..............Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do Not Use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When Using This Product

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

Stop Use And Ask A Doctor If

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Keep Out Of Reach Of Children

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

Directions

  • instill 1 or 2 drops in the affected eye(s) as needed
  • children under 6 years of age: ask a doctor

Other Information

  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at room temperature

Inactive Ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride

Package Label.Principal Display Panel

Carton (Smlubtcart)

Carton (Smlubtcart)

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