T-raojo
FDA Label NDC 58988-0148

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Promex, Llc for the product T-raojo (NDC 58988-0148). 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 active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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

Active Ingredient

  • Tetrahydrozoline HCl 0.5%

Purpose

  • Redness reliever

Use

  • for the relief of redness of the eye due to minor eye irritations

Warnings

Ask a doctor before use if you have narrow angle glaucoma

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 become cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each 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 lasts more than 72 hours

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Other Information

  • store between 15° to 25°C (59°F to 77°F)


Inactive Ingredients

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

Package Label

Redness relief

Image Of Carton Label (Eyedrop.traojo)

Image Of Carton Label (Eyedrop.traojo)

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