LEADER ORIGINAL FORMULA EYE DROPS- tetrahydrozoline hydrochloride solution/ drops

LEADER ORIGINAL FORMULA EYE DROPS by

Drug Labeling and Warnings

LEADER ORIGINAL FORMULA EYE DROPS by is a Otc medication manufactured, distributed, or labeled by HANLIM PHARM. CO., LTD., UNITED EXCHANGE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding

ask a health professional before use

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER ORIGINAL FORMULA EYE DROPS 
tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-4708
Route of Administration	OPHTHALMIC	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-4708-8	1 in 1 CARTON
1		15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/22/2010

Labeler - HANLIM PHARM. CO., LTD. (687986034)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
HANLIM PHARM. CO., LTD.		687986034	manufacture