Eyes Irritation Relief Liquid
FDA Label NDC 70000-0087

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Eyes Irritation Relief (NDC 70000-0087). 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, active ingredient, uses, warnings, do not use if, ask a doctor before use if you have, when using this product, 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

Redness reliever

Active Ingredient

Tetrahydrozoline hydrochloride 0.05%

Uses

  • for the temporary relief of burning & irritation due to dryness of the eye
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • relieves redness of the eye due to minor eye irritations

Warnings

For external use only

Do Not Use If

solution changes color or becomes cloudy.

Ask A Doctor Before Use If You Have

narrow angle glaucoma.

When Using This Product

  • to avoid contamination, do not touch tip to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily

Stop Use & 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
  • symptoms last 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) up to four times daily.

Other Information

  • store at room temperature
  • remove contact lenses before using

Inactive Ingredients

Benzalkonium Chloride,  Disodium Hydrogen Phosphate Anhydrous, Disodium Edetate, Mannitol , Potassium Chloride, Purified Water, Sodium dihydrogen Phosphate Dihydrate, Sodium Chloride, Sodium Citrate , May Contain Hydrochloric Acid and/or Sodium Hydroxide to Adjust PH.

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