Leader Lubricating Eye Drops
FDA Label NDC 11716-1191

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 Lubricating Eye Drops (NDC 11716-1191). 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 - when using, otc - stop use, otc - keep out of reach of children, indications & usage, inactive ingredient, 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

Carboxymethylcellulose Sodium 0.5%-------------------Lubricant

Glycerin 0.9%-----------------------------------------------------Lubricnat

Otc - Purpose

Uses

  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or from irritation from wind or sun.
  • May be used to protect against further irritation.

Warnings

Warnings

  • For external use only

Otc - When Using

When using this product

  • To avoid contamination, do not touch tip of container to any surface.  Replace cap after using.
  • Do not use if solution changes color or gets cloudy.

Otc - Stop Use

Stop use and ask a doctor if

You feel eye pain, changes in vision, continued redness, or irritation of the eye, or if the condition worsens or persists 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 immediately.

Indications & Usage

Directions

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

Inactive Ingredient

Inactive ingredients: Boric Acid, Calcium Chloride Dihydrate, Chlorhexidine Gluconate, Erythritol, Hexahydrate, Levocarnitine, Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Borate Decahydrate, Sodium Citrate Dihydrate

Package Label.Principal Display Panel

Image Of Carton Label (Leaderlubricating)

Image Of Carton Label (Leaderlubricating)

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