Rohto Digi-eye Liquid
FDA Label NDC 10742-8175

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Mentholatum Company for the product Rohto Digi-eye (NDC 10742-8175). 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 ingredients, purpose, uses, warnings, ask a doctor before use if you have, when using this produce, stop use and ask a doctor if, 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 Ingredients

Hypromellose 0.35%

Tetrahydrozoline hydrochloride 0.05%

Purpose

Hypromellose - Lubricant

Tetrahydrozoline hydrochloride - Redness reliever

Uses

  • temporarily relieves burning and irritation due to dryness of the eye
  • relieves redness of the eye due to minor eye irritations

Warnings

For external use only

Ask A Doctor Before Use If You Have

narrow angle glaucoma

When Using This Produce

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • do not use if solution changes color or becomes cloudy
  • overuse may cause more eye redness
  • pupils may become enlarged temporarily
  • remove contact lenses before using

Stop Use And Ask A Doctor If

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eyes lasts
  • condition worsens or lasts more than 72 hours

Keep Out Of Reach Of Children.

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

Directions

  • put 1 or 2 drops in the affected eye(s) up to 4 times daily
  • tightly snap on cap to seal

    • Other information

    • do not store above at 25°C (77°F)

Inactive Ingredients

benzalkonium chloride, boric acid, chlorobutanol, cyanocobalamin, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate

Questions Or Comments?

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