VISINE A.C. ITCHY EYE RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]

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  • VISINE A.C. ITCHY EYE RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]

VISINE A.C. ITCHY EYE RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]
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NDC 69968-0366-1
Set ID 257b9666-0163-499b-9673-bf6f4d6899b1
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 INGREDIENT

    Active ingredientsPurpose
    Tetrahydrozoline HCl 0.05%Redness reliever
    Zinc sulfate 0.25%Astringent
  • Use

    • for temporary relief of discomfort and 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
    • some users may experience a brief tingling sensation

    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
    • children under 2 years of age: do not use
  • Other information

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

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

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    VISINE®

    A.C.
    ITCHY EYE RELIEF

    ASTRINGENT /
    REDNESS RELIEVER EYE DROPS

    RELIEVES ITCHY, RED,
    WATERY EYES

    STERILE
    1/2 FL OZ (15mL)

    Principal Display Panel - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VISINE A.C. ITCHY EYE RELIEF 
    tetrahydrozoline hydrochloride and zinc sulfate, unspecified form solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0366
    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
    Zinc Sulfate, Unspecified Form (UNII: 89DS0H96TB) (Zinc Cation - UNII:13S1S8SF37) Zinc Sulfate, Unspecified Form2.5 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 Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0366-11 in 1 CARTON05/06/2019
    115 mL in 1 BOTTLE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34905/06/2019
    Labeler - Johnson & Johnson Consumer Inc. (002347102)
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