Label: VISINE RED EYE HYDRATING COMFORT EYE DROPS- tetrahydrozoline hydrochloride and polyethylene glycol 400 solution/ drops

  • NDC Code(s): 69968-0356-1, 69968-0356-2, 69968-0356-3, 69968-0356-4
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Polyethylene glycol 400 1%Lubricant
    Tetrahydrozoline HCl 0.05%Redness reliever
  • Uses

    • for the relief of redness of the eye due to minor eye irritations
    • for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
    • for use as a protectant against further irritation or to relieve dryness of the eye
  • 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

    • 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

    ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

  • 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 ®
    RED EYE
    HYDRATING
    COMFORT
    LUBRICANT/REDNESS RELIEVER EYE DROPS

    WORKS IN 30 SECONDS
    Redness + Irritation Relief

    Lubricates +
    Refreshes
    STERILE
    1/2 FL OZ (15mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VISINE RED EYE HYDRATING COMFORT  EYE DROPS
    tetrahydrozoline hydrochloride and polyethylene glycol 400 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0356
    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
    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)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCINE (UNII: TE7660XO1C)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POLIXETONIUM CHLORIDE (UNII: RNW5AM67C0)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0356-21 in 1 CARTON04/27/2020
    115 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    2NDC:69968-0356-1700 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK04/27/2020
    28 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    3NDC:69968-0356-31 in 1 CARTON04/27/2020
    38 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    4NDC:69968-0356-41 in 1 BLISTER PACK04/27/2020
    48 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
    Labeler - Kenvue Brands LLC (118772437)
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