Label: LEADER ORIGINAL FORMULA EYE DROPS- tetrahydrozoline hydrochloride solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: OTC monograph final

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 Label Information

Updated March 18, 2010

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!