LEADER ORIGINAL FORMULA EYE DROPS - tetrahydrozoline hydrochloride solution/ drops 
HANLIM PHARM. CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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


Ask a doctor before use if you have narrow angle glaucoma

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 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


If pregnant or breast-feeding

ask a health professional before use

Keep out of the reach of children

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


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

children under 6 years of age: ask a doctor


Other information

some users may experience a brief tingling sensation

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


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

image of carton labelEnter section text here

LEADER ORIGINAL FORMULA EYE DROPS 
tetrahydrozoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-4708
Route of AdministrationOPHTHALMICDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-4708-81 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/22/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
HANLIM PHARM. CO., LTD.687986034manufacture

Revised: 3/2010
Document Id: 312b0852-6077-491f-ae04-3a079d9bb885
Set id: c815b41d-811f-4e4c-929a-383727074f91
Version: 5
Effective Time: 20100318
 
HANLIM PHARM. CO., LTD.