SUNMARK REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) LIQUID [MCKESSON CORPORATION]

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SUNMARK REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) LIQUID [MCKESSON CORPORATION]
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NDC 49348-894-29
Set ID 47fc9b82-6920-4bee-a34d-2658ddee6ca3
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active Ingredients

    Glycerin 0.2%

    Naphazoline hydrochloride 0.012%

  • Purpose

    Lubricant and redness reliver

  • Uses

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

    For external use only

    Do not use this product if

    • solution changes color or become cloudy

    Ask a doctor before use

    if you have narrow angle glaucoma

    when using this product

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

    Stop use and ask a doctor if

    • you feel 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 right away.

  • Directions

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

  • Other information

    • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
    • store at room temperature
    • remove contact lenses before using
  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    SUNMARK REDNESS RELIEF 
    glycerin, naphazoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-894
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.2 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:49348-894-291 in 1 CARTON10/01/2009
    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 finalpart34910/01/2009
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(49348-894) , pack(49348-894) , label(49348-894)
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