Label: LEADER ADVANCED RELIEF EYE DROPS- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    ​Active ingredients

    Dextran 70 0.1%

    Polyethylene glycol 400 1%

    Povidone 1%

    Tetrahydrozoline HCl 0.05%

  • PURPOSE

    ​Purposes

    Dextran 70...Lubricant

    Polyethylene glycol 400...Lubricant

    Povidone...Lubricant

    Tetrahydrozoline HCl...Redness reliever

  • INDICATIONS & USAGE

    Uses

    • relieves redness of the eye due to minor eye irritations
    • as a lubricant to prevent further irritation or to relieve dryness of the eye
  • WARNINGS

    Warnings

    For external use only

    Ask a doctor before use if you have narrow angle glaucoma

    When using this product

    • pupils may become enlarged temporarily
    • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
    • if solution changes color or becomes cloudy, do not use
    • overuse may produce increased redness of the eye
    • remove contact lens before using

    Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

  • OTHER SAFETY INFORMATION

    Other information

    • Store at 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • Questions or comments?

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  • Leader Advanced Relief Eye Drops 15mL

    Leader Advanced Relief Eye Drops 15ml

  • INGREDIENTS AND APPEARANCE
    LEADER ADVANCED RELIEF EYE DROPS 
    dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0456
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70100 mg  in 100 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001000 mg  in 100 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE1000 mg  in 100 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE50 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0456-11 in 1 BOX02/19/2019
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01802/19/2019
    Labeler - Cardinal Health (063997360)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(70000-0456) , label(70000-0456) , pack(70000-0456)
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