FDA Label for Optic Splash

View Indications, Usage & Precautions

Optic Splash Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical, Co., Ltd.. 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.

Otc - Active Ingredient



Active ingredients
Glycerin 0.2%
Naphazoline hydrochloride 0.02%


Otc - Purpose



Purpose
Glycerin     Lubricant
Naphazoline hydrochloride     Redness reliever


Indications & Usage



Uses
■ Relieves redness of the eye due to minor eye irritations.
■ Temporarily relieves burning and irritation due to dryness of the eye.


Warnings



Warnings
For external use only


Otc - Do Not Use



Do not use
■ if solution changes color or becomes cloudy


Otc - Ask Doctor



Ask a doctor before use if you have
■ narrow angle glaucoma

Stop use and ask a doctor if
■ you experience:
    ■ eye pain    ■ changes in vision
    ■ continued redness or irritation of the eye
■ condition worsens or persists for more than 72 hours


Otc - When Using



When using this product
■ to avoid contamination, do not touch tip of container to any surface
■ replace cap after using
■ overuse of this product may produce increased redness of the eye
■ pupils may become enlarged temporarily


Otc - Keep Out Of Reach Of Children



Keep our of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions
Instill 1 to 2 drops in the affected eye(s) up to four times daily.


Other Safety Information



Other information
■ store tightly closed, protected from light.


Inactive Ingredient



Inactive ingredients
benzalkonium chloride, boric acid, camphor, menthol, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride


Package Label.Principal Display Panel



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