Label: TOPCARE MAXIMUM REDNESS RELIEF EYE DROPS- glycerin, naphazoline hydrochloride solution

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

Drug Label Information

Updated December 20, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Glycerin.....0.5%

    Naphazoline hydrochloride....0.03%

  • PURPOSE

    Purpose

    Glycerin..................................Lubricant

    Naphazoline hydrochloride.....Redness reliever

  • INDICATIONS & USAGE

    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

    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 right away.

  • DOSAGE & ADMINISTRATION

    Directions

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

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature
    • remove contact lenses before using
    • Tamper evident: Do not use this product if imprinted neckband is missing or broken
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    TOPCARE MAXIMUM REDNESS RELIEF EYE DROPS 
    glycerin, naphazoline hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-975
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.5 g  in 100 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.03 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-975-011 in 1 CARTON02/04/2020
    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 DrugM01802/04/2020
    Labeler - Topco Assoc LLC (006935977)
    Registrant - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(36800-975) , pack(36800-975) , label(36800-975)
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