FDA Label for Rohto Digi-eye
View Indications, Usage & Precautions
Rohto Digi-eye Product Label
The following document was submitted to the FDA by the labeler of this product The Mentholatum Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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• do not store above at 25°C (77°F)
Other information
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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