Leader Eye Drops Redness Relief Solution/ Drops
FDA Label NDC 70000-0010

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 for the product Leader Eye Drops Redness Relief (NDC 70000-0010). 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, purposes, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Purposes

Glycerin...Lubricant

Naphazoline hydrochloride...Redness reliever

Uses

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

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 of container to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily

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 or 2 drops in the affected eye(s) up to 4 times daily

children under 6 years of age:ask a doctor

Other Information

  • store at room temperature
  • remove contact lenses before using

Inactive Ingredients

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

Questions Or Comments?

Call 1-888-527-4276

Package Label.Principal Display Panel

Carton (Leadeyedredrel)

Carton (Leadeyedredrel)

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