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
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