Shopko Dry Eye Relief
FDA Label NDC 11716-1629

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 Shopko Dry Eye Relief (NDC 11716-1629). 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 - when using, otc - stop use, otc - pregnancy or breast feeding, 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 ingredients                                                        Purpose

Glycerin 0.2% ............................................................Lubricant

Hypromellose 0.2% .....................................................Lubricant

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

Otc - Purpose

Uses

  • for the tmeporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation

Otc - When Using

When using this product

  • remove contact lenses before using
  • do not use if this solution changes color or become 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) as needed
  • 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: ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycine magnesium chloride,

potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, and sodium lactate

Package Label.Principal Display Panel

Image Of Carton Label (Shopkodereyedrops)

Image Of Carton Label (Shopkodereyedrops)

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