Label: SIGNATURE CARE EYE DROPS REDNESS AND DRY EYE RELIEF- glycerin, naphazoline hydrochloride solution/ drops

  • NDC Code(s): 21130-703-01
  • Packager: Better Living Brands LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 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 burining 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
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens
    • symptoms last 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

  • Other information

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

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

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE EYE DROPS REDNESS AND DRY EYE RELIEF 
    glycerin, naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-703
    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:21130-703-011 in 1 CARTON10/05/2018
    115 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 DrugM01810/05/2018
    Labeler - Better Living Brands LLC (009137209)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(21130-703) , pack(21130-703) , label(21130-703)
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