Label: LEADER EYE DROPS REDNESS RELIEF- glycerin, naphazoline hydrochloride solution/ drops

  • NDC Code(s): 70000-0010-1, 70000-0010-2
  • Packager: Cardinal Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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  • Active ingredients

    Glycerin 0.25%

    Naphazoline hydrochloride 0.012%

  • Purposes

    Glycerin...Lubricant

    Naphazoline hydrochloride...Redness reliever

  • Uses

    • for the relief of redness of the eye due to minor eye irritations
    • for the temporary relief of burning and irritation due to dryness of the eye 
    • for use as a protectant against further irritation or dryness of the eye
  • Warnings

    For external use only

    Do not use

    • if solution changes color or becomes cloudy

    Ask a doctor before use if you have

    narrow angle glaucoma

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using
    • overuse may produce increased redness of the eye
    • pupils may become enlarged temporarily

    Stop use and ask a doctor if

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

    Keep out of reach of children

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

  • Directions

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

    children under 6 years of age:ask a doctor

  • Other information

    • store at room temperature
    • remove contact lenses before using
  • Inactive ingredients

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

  • Questions or comments?

    Call  1-888-527-4276

  • PRINCIPAL DISPLAY PANEL

    carton

  • PRINCIPAL DISPLAY PANEL

    Twin size

  • INGREDIENTS AND APPEARANCE
    LEADER EYE DROPS REDNESS RELIEF 
    glycerin, naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0010
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.25 g  in 100 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.012 g  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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0010-11 in 1 CARTON04/30/2019
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:70000-0010-22 in 1 CARTON04/30/2019
    215 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01804/30/2019
    Labeler - Cardinal Health (063997360)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(70000-0010) , pack(70000-0010) , label(70000-0010)
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