Label: LEADER ADVANCED FORMULA- dextran70, polyethylene glycol, povidone, tetrahydrozoline hcl 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 November 29, 2016

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

  • ACTIVE INGREDIENT

    Active ingredients                                                               Purpose

    Dextran 70 0.1%................................................................Lubricant

    Polyethylene glycol 400 1%.................................................Lubricant

    Povidone 1%......................................................................Lubricant

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

  • PURPOSE

    Uses

    • for the relief of redness of the eyes due to minor eye irritations
    • for use as a protectant against further irritation or to relieve dryness of the eye

  • WARNINGS

    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 becomes 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

    Directions

    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    some users may experience a brief tingling sensation

    store at 15o to 25oC (59o to 77oF)

  • INACTIVE INGREDIENT

    Inactive ingredients:

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 3256021

    www.myleader.com

    1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER ADVANCED FORMULA 
    dextran70, polyethylene glycol, povidone, tetrahydrozoline hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-224
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    POVIDONES (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONES10 mg  in 1 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 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 BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-224-051 in 1 CARTON11/29/2016
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/04/2012
    Labeler - CARDINAL HEALTH (097537435)