FDA Label for Rohto Cool Relief
View Indications, Usage & Precautions
Rohto Cool Relief 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
Naphazoline hydrochloride 0.012%
Polysorbate 80 0.2%
Purpose
Naphazoline hydrochloride - Redness reliever
Polysorbate 80 - Lubricant
Uses
• relieves redness of the eye due to minor eye irritations• for use as a lubricant to prevent further irritation or to relieve dryness of the eye• for protection against further irritation
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• 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 25°C (77°F)
Other information
Inactive Ingredients
alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate
Questions?
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