Label: SIGNATURE CARE EYE DROPS REDNESS AND DRY EYE RELIEF- glycerin, naphazoline hydrochloride liquid

  • NDC Code(s): 21130-703-01
  • Packager: Better Living Brands LLC
  • 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 January 27, 2019

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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

    PDP

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE EYE DROPS REDNESS AND DRY EYE RELIEF 
    glycerin, naphazoline hydrochloride liquid
    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 finalpart34910/05/2018
    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)