Label: LEADER RELIEF- tetrahydrozoline hydrochloride and zinc sulfate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • 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 October 8, 2010

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

  • ACTIVE INGREDIENT

    Active ingredients                                                                            Purpose

    Tetrahydrozoline HCL 0.05% ...........................................................Redness Reliever

    Zinc Sulfate 0.25% .........................................................................Astringent

  • PURPOSE

    Uses

    • for the temporary relief of redness and irritation of the eye and for use as a protectant against further irritation.
    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use: If this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

  • WHEN USING

    When using this product

    • remove contact lenses before using
    • 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 eye gets worse 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

    Directions

    • instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
    • Store at room temperature.
    • Children under 6 years of age: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients: Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Chloride, Sodium Citrate

  • DOSAGE & ADMINISTRATION

    Distributed By Cardinal Health

    Dublin, OH 43017

    CIN 1963735

    www.myleader.com

    1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    LEADER RELIEF  
    tetrahydrozoline hydrochloride and zinc sulfate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-9638
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC - UNII:J41CSQ7QDS) ZINC SULFATE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11716-9638-31 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/08/2010
    Labeler - HANLIM PHARM. CO., LTD. (687986034)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANLIM PHARM. CO., LTD.687986034manufacture