Winco Maximum Redness Relief Eye Drops Solution/ Drops
FDA Label NDC 67091-285

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 Maximum Redness Relief Eye Drops (NDC 67091-285). 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 - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

​Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%

Otc - Purpose

​Purpose

Glycerin...Lubricant

Naphazoline hydrochloride...Redness reliever

Indications & Usage

Uses

  • For the relief of redness of the eye due to minor eye irritations
  • For the temporary relief of burning and irritation due to dryness of the eye
  • For use as a protectant against further irritation or dryness of the eye

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use if solution changes color or becomes cloudy

Otc - Ask Doctor

Ask a doctor before use if you have narrow angle glaucoma

Otc - When Using

When using this product

  • To avoid contamination, do not touch tip of container to any surface
  • Replace cap after using
  • Overuse may produce increased redness of the eye
  • Pupils may become enlarged temporarily

Otc - Stop Use

Stop use and ask a doctor if

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

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 room temperature
  • remove contact lenses before using
    • Tamper Evident: Do not use this product if imprinted neckband is missing or broken

Inactive Ingredient

Inactive ingredients

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

Package Label.Principal Display Panel

Carton (Maxredcart)

Carton (Maxredcart)

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