LEADER ORIGINAL FORMULA EYE DROPS

Dosage form: solution/ drops
Ingredients: TETRAHYDROZOLINE HYDROCHLORIDE 0.5mg in 1mL
Labeler: HANLIM PHARM. CO., LTD.
NDC Code: 11716-4708

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.

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

Enter 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 (TETRAHYDROZOLINE ) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
SODIUM CHLORIDE 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:11716-4708-81 BOTTLE (BOTTLE) 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/FEIOperations
HANLIM PHARM. CO., LTD.687986034manufacture

Revised: 03/2010
 
HANLIM PHARM. CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)