Freds Astringent Rdeness Reliever Eye
FDA Label NDC 55315-124

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Freds Inc for the product Freds Astringent Rdeness Reliever Eye (NDC 55315-124). 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 - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, 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

Tetrahydrozoline HCl 0.05%......................................................Redness Reliever

Zinc Sulfate 0.25%..............................................................................Astringent

Otc - Purpose

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
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tips 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 they 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 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
  • Children under 6 years of age: Ask a doctor

Storage And Handling

Other information

  • some users may experience a brief tingling sensation
  • store between 15°-25°C (59°-77°F)

Inactive Ingredient

Inactive ingredients benzalkonium chloride, boric acid, disodium edetate hydrate, purified water, sodium chloride, sodium citrate

Dosage & Administration

Distributed By:

Fred's Inc.

4300 New Getwell Rd.

Memphis, TN 38118

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Fredsreliefed)

Image Of Carton Label (Fredsreliefed)

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