Label: VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF- tetrahydrozoline hcl, polyethylene glycol 400, zinc sulfate kit

  • NDC Code(s): 69968-0360-1, 69968-0363-1, 69968-0844-9
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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  • SPL UNCLASSIFIED SECTION

    VISINE ® Red Eye Total Comfort Multi-Symptom

    Drug Facts

  • Active ingredient

    Polyethylene glycol 400 1%

    Tetrahydrozoline HCl 0.05%

    Zinc sulfate 0.25%

  • Purpose

    Lubricant

    Redness reliever

    Astringent

  • Uses

    • for the temporary relief of discomfort and redness of the eye due to minor eye irritations
    • relieves dryness of the eye
    • for the temporary relief of burning and irritation due to exposure to wind or sun
    • for protection against further irritation
  • Warnings

    For external use only

    Ask a doctor before use if you have narrow angle glaucoma.

    When using this product

    • some users may experience a brief tingling sensation
    • 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

    • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day

    • children under 6 years of age: consult a doctor

    • children under 2 years of age: do not use

  • Other information

    Store at 20° to 25°C (68° to 77°F)

  • Inactive ingredients

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

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    VISINE ® Dry Eye Relief

    Drug Facts

  • Active ingredient

    Polyethylene glycol 400 1%

  • Purpose

    Lubricant

  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for protection against further irritation
  • Warnings

    For external use only

    When using this product

    • 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

    • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) as needed

    • children under 6 years of age: consult a doctor

  • Other information

    Store at room temperature

  • Inactive ingredients

    ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycerin, glycine, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

  • 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 - Kit Package

    VALUE

    MULTI-PACK

    VISINE ®

    RED EYE

    TOTAL COMFORT

    MULTI-SYMPTOM

    ASTRINGENT / LUBRICANT / REDNESS RELIEVER EYE DROPS

    UP TO

    10 HRS

    COMFORT

    ALL-IN ONE RELIEF

    From Red, Burning,

    Watery, Itchy, Dry, Gritty,

    Irritated Eyes

    Protects Against

    Further Irritation

    STERILE

    Use products only

    as directed.

    DRY EYE

    RELIEF

    LUBRICANT EYE DROPS

    MOISTURIZES +

    SOOTHES DRY,

    GRITTY EYES

    Designed to Work

    Like Real

    Tears

    1 BOTTLE: VISINE®

    RED EYE TOTAL COMFORT MULTI-SYMPTOM

    ½ FL OZ (15 mL)

    1 BOTTLE: VISINE® DRY EYE RELIEF ½ FL OZ (15 mL)

    Visine_01

  • INGREDIENTS AND APPEARANCE
    VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF 
    tetrahydrozoline hcl, polyethylene glycol 400, zinc sulfate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0844
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0844-91 in 1 PACKAGE06/08/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DROPPER 15 mL
    Part 21 BOTTLE, DROPPER 15 mL
    Part 1 of 2
    VISINE RED EYE TOTAL COMFORT MULTI-SYMPTOM 
    tetrahydrozoline hydrochloride, polyethylene glycol 400, and zinc sulfate, unspecified form solution/ drops
    Product Information
    Item Code (Source)NDC:69968-0360
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0360-11 in 1 CARTON
    115 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 DrugM01804/27/2020
    Part 2 of 2
    VISINE DRY EYE RELIEF 
    polyethylene glycol 400 solution/ drops
    Product Information
    Item Code (Source)NDC:69968-0363
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCINE (UNII: TE7660XO1C)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    BORIC ACID (UNII: R57ZHV85D4)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0363-11 in 1 CARTON
    115 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 DrugM01804/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01806/08/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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