Leader Eye Itch Relief Drops
FDA Label NDC 11716-1163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hanlim Pharm. Co., Ltd. for the product Leader Eye Itch Relief Drops (NDC 11716-1163). 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, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                             Purpose

Ketotifen (0.025%)..........................................Antihistamine

(Equivalent to ketotifen fumarate 0.035%)

Otc - Purpose

Use

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Otc - Do Not Use

Warnings

Do not use

  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

Otc - When Using


When using this product
  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eye
  • itching worsens or lasts for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

  • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
  • Children under 3 years of age: Consult a doctor

Storage And Handling

Other information

  • Only for use in the eye
  • Store between 20o-25oC (68o to 77oF) (See USP controlled Room Temperature)
  • Do not use if cap seal ring is broken

Inactive Ingredient

Inactive ingredients

benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and water for injection

Package Label.Principal Display Panel

Image Of Carton Label (Leadereyeitchrelief)

Image Of Carton Label (Leadereyeitchrelief)

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