Winco Irritation Relief Eye Solution/ Drops
FDA Label NDC 67091-283

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Irritation Relief Eye (NDC 67091-283). 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, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, pregnancy, 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

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Otc - Purpose

​Purpose

Tetrahydrozoline HCl...Redness Reliever

Zinc sulfate...Astringent

Indications & Usage

Uses

  • for temporary relief of discomfort and redness of the eye due to minor eye irritations

Warnings

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have narrow angle glaucoma

Otc - When Using

When using this product

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

Otc - Stop Use

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Pregnancy

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Other Safety Information

Other information

Store at 15°-30°C (59°-86°F)

Inactive Ingredient

Inactive ingredients

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

Package Label.Principal Display Panel

Carton (Irrrelcart)

Carton (Irrrelcart)

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