Shopko Relief
FDA Label NDC 11716-0460

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 Relief (NDC 11716-0460). 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

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

Ask a doctor before use if you have narrow 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 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

  • Instill 1 or 2 drops in the affected eye(s) up to 4 times daily
  • Store at 15o to 25oC (59o to 77oF)
  • 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

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

www.ueccorp.com

Package Label.Principal Display Panel

Image Of Carton Label (Shopkoreliefeyedrops)

Image Of Carton Label (Shopkoreliefeyedrops)

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