Leader Relief
FDA Label NDC 11716-9638

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 Relief (NDC 11716-9638). 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 - pregnancy or breast feeding, otc - keep out of reach of children, 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

Tetrahydrozoline HCL 0.05% ...........................................................Redness Reliever

Zinc Sulfate 0.25% .........................................................................Astringent

Otc - Purpose

Uses

  • for the temporary relief of redness and irritation of the eye and for use as a protectant against further irritation.
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

Warnings

Warnings

For external use only.

Otc - Do Not Use

Do not use: If this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

Otc - When Using

When using this product

  • remove contact lenses before using
  • 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 eye gets worse 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

  • instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
  • Store at room temperature.
  • Children under 6 years of age: Ask a doctor

Inactive Ingredient

Inactive Ingredients: Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Chloride, Sodium Citrate

Dosage & Administration

Distributed By Cardinal Health

Dublin, OH 43017

CIN 1963735

www.myleader.com

1-800-200-6313

Package Label.Principal Display Panel

Image Of Carton Label (Leaderreliefeyedrops)

Image Of Carton Label (Leaderreliefeyedrops)

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