Rohto Liquid
FDA Label NDC 10742-8146

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 (NDC 10742-8146). 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, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Hypromellose 0.2%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purpose

Hypromellose - Lubricant

Tetrahydrozoline HCl - Redness reliever

Zinc sulfate - Astringent

Uses

  • temporarily relieves redness of the eye and discomfort due to
    • ∘minor eyes irritations
    • ∘exposure to wind or sun
    • temporarily relieves burning and irritation due to dryness of the eye

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

When Using This Product

  • 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

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

    • store at 20-25°C (68-77°F)

Inactive Ingredients

boric acid, edetate disodium, menthol, polysorbate 80, purified water, sodium borate

Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

* Please review the disclaimer below.