Active Ingredient
Hypromellose 0.3%
Povidone 0.5%
Rohto Liquid
FDA Label NDC 66613-8459
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rohto Pharmaceutical Co., Ltd. for the product Rohto (NDC 66613-8459). 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
Purpose
Hypromellose – Lubricant
Povidone - Lubricant
Uses
- for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
- 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
- replace cap after each use
- do not use if solution changes color or becomes cloudy
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 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
- put 1 or 2 drops in the affected eye(s) as needed
- tightly snap on cap to seal
- do not store above 25 OC (77 OF)
Other information
Inactive Ingredients
alginic acid, anhydrous citric acid, boric acid, camphor, chlorobutanol, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium citrate, taurine, zinc sulfate
Questions?
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