EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HONEYWELL SAFETY PRODUCTS USA, INC]

EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-0161-15
Set ID 703645d0-5157-7a83-e053-2a91aa0a903e
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, INC
Generic Name
Product Class
Product Number
Application Number PART349
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Tetrahydrozoline HCl 0.05%

  • PURPOSE

    Purpose

    Redness reliever

  • INDICATIONS & USAGE

    Uses

    relieves redness of the eye due to minor eye irritations

  • 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

    • pupils may become enlarged temporarily
    • overuse may produce increased redness of the eye
    • remove contact lenses before using
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • the condition worsens or persists for more than 72 hours

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

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

  • DOSAGE & ADMINISTRATION

    Directions

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

  • STORAGE AND HANDLING

    Other information Store at 15° to 30°C (59° to 86°F)

  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    • Tamper evident. Do not use this product if imprinted neckband is missing or broken.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE

    Distributed by

    North by Honeywell

    900 Douglas Pike

    Smithfield, RI 02917

    Questions? Call 800-430-5490

  • PRINCIPAL DISPLAY PANEL

    Eye Drops

  • INGREDIENTS AND APPEARANCE
    EYE DROPS 
    tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0161
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0161-151 in 1 CARTON07/04/2018
    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 finalpart34907/04/2018
    Labeler - Honeywell Safety Products USA, INC (079287321)

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