Sound Body Original Eye
FDA Label NDC 65923-559

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp for the product Sound Body Original Eye (NDC 65923-559). 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 drug facts, 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

Drug Facts

Active ingredient                                                                  Purpose

Tetrahydrozoline HCl 0.05%                                        Redness Reliever

Otc - Purpose

Uses

For the relief of redness of the eyes due to minor eye irritations

Warnings

Warnings

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 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 last 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

  • put 1 to 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 at 15° to 25°C (59° to 77°F)

Inactive Ingredient

Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Dosage & Administration

Distributed By:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

Made in Korea

Package Label.Principal Display Panel

Image Description (Sboriginaleyedrops)

Image Description (Sboriginaleyedrops)

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