Otc - Active Ingredient
Tetrahydrozoline HCL 0.05%....................Redness reliever
Leader Original Formula Eye Drops
FDA Label NDC 11716-4708
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hanlim Pharm. Co., Ltd. for the product Leader Original Formula Eye Drops (NDC 11716-4708). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Image Of Carton Label (Originalformula)
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