Sunmark Dry Eye Relief Solution/ Drops
FDA Label NDC 49348-095

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 Dry Eye Relief (NDC 49348-095). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - 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

Otc - Active Ingredient

​Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%

Otc - Purpose

​Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant

Indications & Usage

​Uses

  • for the temporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation

Warnings

​Warnings

For external use only

Otc - Do Not Use

Do not use this product if solution changes color or becomes cloudy

Otc - Ask Doctor

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

Otc - When Using

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed
  • remove contact lens before using

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

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

Otc - Pregnancy Or Breast Feeding

If pregnant and breast-feeding, ask a health professional before use

Dosage & Administration

Directions

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

Other Safety Information

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE

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

Inactive Ingredient

​Inactive ingredients

dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water

Package Label.Principal Display Panel

Carton (Smdryeye Cart)

Carton (Smdryeye Cart)

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