Walgreens Maximum Redness Relief
FDA Label NDC 0363-1465

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Maximum Redness Relief (NDC 0363-1465). 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 - ask doctor, otc - when using, otc - stop use, 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

Glycerin 0.5% ................................................................. Lubricant

Naphazoline HCL 0.03% ................................................... Redness reliever

Otc - Purpose

 Uses

  • for the relief of redness of the eye due to minor eye irritations.
  • for the temporary relief of burning and irritation due to the dryness of the eye.
  • for the 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 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

Indications & Usage

 Directions

  • to open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning.
  • put 1 to 2 drops in the affected eye(s) up to 4 times daily

Storage And Handling

 Other information

  • store at room temperature (15° to 30°C 59° to 86°F)
  • remove contact lenses before using

Inactive Ingredient

 Inactive ingredients

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

Dosage & Administration

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD.

DEERFIELD, IL 60015

walgreens.com

Made in Korea

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