VISINE ORIGINAL REDNESS RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]

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  • VISINE ORIGINAL REDNESS RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]

VISINE ORIGINAL REDNESS RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]
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NDC 42002-203-02, 42002-203-35
Set ID e3c41a58-fc93-4e6c-99be-0529edfb54a4
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Tetrahydrozoline HCl 0.05%

  • Purpose

    Redness reliever

  • Use

    • for the relief of redness of the eye due to minor eye irritations
  • Warnings

    For external use only.

    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 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 eye lasts
    • condition worsens or lasts 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.

  • Directions

    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • Other information

    • store at 15° to 25°C (59° to 77°F)
  • Inactive ingredients

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

  • Questions?

    call toll-free 888-734-7648 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Dist: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman, NJ 08558 USA

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Sterile
    Visine®

    ORIGINAL
    Redness Relief
    TETRAHYDROZOLINE HCl
    REDNESS RELIEVER EYE DROPS

    Gets the
    Red Out®

    Fast-acting
    formula

    1/2 FL OZ (15mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VISINE ORIGINAL   REDNESS RELIEF
    tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-203
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D) (Tetrahydrozoline - UNII:S9U025Y077) Tetrahydrozoline Hydrochloride0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Boric Acid (UNII: R57ZHV85D4)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42002-203-021 in 1 CARTON10/01/200909/30/2022
    115 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    2NDC:42002-203-351 in 1 CARTON10/01/200908/31/2016
    219 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34910/01/200909/30/2022
    Labeler - Johnson & Johnson Consumer Inc. (002347102)
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