FDA Label for Leader Original Formula Eye Drops

View Indications, Usage & Precautions

Leader Original Formula Eye Drops Product Label

The following document was submitted to the FDA by the labeler of this product Hanlim Pharm. 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



Tetrahydrozoline HCL 0.05%....................Redness reliever

Otc - Purpose



For the relief of redness of the eyes due to minor eye irritations.



Warnings



Ask a doctor before use if you have narrow angle glaucoma


Otc - When Using



When Using this product

pupils may become enlarged temporarily

overuse may cause more eye redness

remove contact lenses before using

do not use if this solution changes color or become cloudy

do not touch tip of container to any surface to avoid contamination

replace cap after each use


Otc - Stop Use



Stop use and ask a doctor if

you feel eye pain

changes in vision occur

redness or irritation of the eye lasts

condition worsens or lasts more than 72 hours



Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding

ask a health professional before use


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children

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



Indications & Usage



put 1 to 2 drops in the affected eye(s) up to 4 times daily

children under 6 years of age: ask a doctor



User Safety Warnings



Other information

some users may experience a brief tingling sensation

store at 15 to 25C (59 to 77F)



Inactive Ingredient



benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate


Package Label.Principal Display Panel



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