Leader Lubricant Eye Drops
FDA Label NDC 11716-1192

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 Lubricant Eye Drops (NDC 11716-1192). 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, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, 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-------------------------------------------------Purpose

Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant

Propylene Glycol (0.3%)---------------------------------------Lubricant

Otc - Purpose

Uses

For the temporary relief of burning and irritation due to eye dryness.

Warnings

Warnings

For external use only.

Otc - Do Not Use

Do not use

  • if solution changes color or becomes cloudy
  • if you are sensitive or allergic to any ingredient in this product

Otc - When Using

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts 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 immediately.

Indications & Usage

Directions

  • Put 1 or 2 drops in the affected eye/s as needed.

Inactive Ingredient

Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride

Package Label.Principal Display Panel

Image Of Carton Label (Leaderlubricant)

Image Of Carton Label (Leaderlubricant)

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