Label: CAREALL EYEDROPS ORIGINAL- tetrahydrozoline hci solution/ drops

  • NDC Code(s): 51824-039-05
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • ACTIVE INGREDIENT

    Tetrahydrozoline HCl 0.05%

  • PURPOSE

    Redness Reliever

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

  • Use

    For the relief of redness of the eye due to minor eye irritations

  • WARNINGS

    Ask a doctor before use if you have narrow angle glaucoma

    When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • do not touch the tip of container to any surface to avoid contamination
    • replace cap after each use

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eyes last
    • condition worsens or lasts more than 72 hours

    If pregnant or breast feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Put 1 to 2 drops in the effected eye(s) up to 4 times daily. 

    Children under 6 years of age: ask a doctor

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Distributed by: NWI, Inc.  160 Athens Way.  Nashville, TN 37228

    (615)329-1906

  • PRINCIPAL DISPLAY PANEL

    label
  • INGREDIENTS AND APPEARANCE
    CAREALL EYEDROPS ORIGINAL 
    tetrahydrozoline hci solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-039
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-039-0515 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01806/01/2014
    Labeler - New World Imports, Inc (075372276)
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