Leader Advanced Formula Eye Drops
FDA Label NDC 11716-1104

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 Advanced Formula Eye Drops (NDC 11716-1104). 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 - pregnancy or breast feeding, 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

Dextran 70 0.1%.................................................................Lubricant

Polyethylene glycol 400 1%.................................................Lubricant

Povidone 1%......................................................................Lubricant

Tetrahydrozoline HCL 0.05%................................................Redness reliever

Otc - Purpose

Uses

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

Warnings

Warnings

Ask a doctor before use if you have narrow angle glaucoma

Otc - When Using

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions

  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor

Storage And Handling

Other information

some users may experience a brief tingling sensation

store at 15o to 25oC (59o to 77oF)

Inactive Ingredient

Inactive ingredients:

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

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