Stye Solution/ Drops
FDA Label NDC 63029-324

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Stye (NDC 63029-324). 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

Polyvinyl alcohol 0.5%
Povidone 0.6%

Purpose

Lubricant
Lubricant

Uses

For temporary relief of discomfort due to minor irritations including: burning, stinging, itching.

Warnings

for external use only

Do Not Use

if solution changes color or becomes cloudy

When Using This Product

  • to avoid contamination, do not touch tip to any surface
  • replace cap after using

Stop Use And Ask A Doctor If

  • you experience eye pain
  • you experience changes in vision
  • you experience 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 (1-800-222-1222) right away

Directions

instill 1 to 2 drops in the affected eye(s) as needed

Other Information

  • store at room temperature 
  • remove contact lenses before using

Inactive Ingredients

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

Questions?

1-800-344-7239

Principal Display Panel

Stye ™

LUBRICANT EYE DROPS

STERILE       0.5 fl oz (15 mL)

Stye ™lubricant Eye Dropssterile 0.5 Fl Oz (15 mL) (Stye Eye Drops 63029 324 01)

Stye ™lubricant Eye Dropssterile 0.5 Fl Oz (15 mL) (Stye Eye Drops 63029 324 01)

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