Rohto Liquid
FDA Label NDC 10742-8161

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 10742-8161). 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, 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 Ingredient

Povidone 0.68%

Propylene glycol 0.3%

Purpose

Povidone – Lubricant

Propylene glycol - Lubricant

Uses

  • temporarily relieves burning and irritation due to dryness of the eye
  • protects against further irritation or to relieve dryness of the eye

Warnings

For external use only

When Using This Product

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard
  • do not use if solution changes color or becomes cloudy

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

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

Directions

  • twist tab completely to remove; do not pull tab off
  • instill 1 or 2 drops in the affected eye(s) as needed
  • discard container

    • Other information

    • use only if single-use container is intact
    • do not freeze

Inactive Ingredients

boric acid, calcium chloride, edetate disodium, magnesium sulfate, menthol, PEG-10 castor oil, poloxamer, polyoxyl stearate, purified water, sesame oil, sodium borate

Questions?

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