Sunmark Eye Drops Advanced Moisturizer/lubricant Solution/ Drops
FDA Label NDC 49348-697

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 Eye Drops Advanced Moisturizer/lubricant (NDC 49348-697). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if you experience, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Dextran 70 0.1%
povidone 1%
Polyethylene glycol 400 1%
Tetrahydrozoline HCL 0.05%

Purpose

Eye Lubricant

Redness reliever

Uses

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

Ask A Doctor Before Use If You Have

narrow angle glucoma

When Using This Product

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • if solution changes color or become cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

Stop Use And Ask A Doctor If You Experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

If Pregnant Or Breast-Feeding

ask a healthcare professional before use

Keep Out Of Reach Of Children

If accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Other Information

Store at 15o- 30oC (59o- 86oF)

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Package Label.Principal Display Panel

Carton (Sunmarkeyedradvmcart)

Carton (Sunmarkeyedradvmcart)

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