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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 20, 2022

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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
    • replace cap after each use
    • do not use if this solution changes color or becomes cloudy
    • do not touch tip of container to any surface to avoid contamination

    Stop use and ask a doctor if

    • you feel eye pain
    • redness or irritation of the eye lasts
    • changes in vision occur
    • 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

    Product Repackaged and Distributed by:
    Select Corporation Carrollton, TX 75007

    Distributed by: Johnson & Johnson Consumer Inc.
    Skillman, NJ 085598

  • PRINCIPAL DISPLAY PANEL - 8 mL Bottle Blister Pack

    VISINE®

    RED EYE
    HYDRATING
    COMFORT
    LUBRICANT/REDNESS RELIEVER EYE DROPS

    WORKS
    IN 30
    SECONDS

    Redness +
    Irritation
    Relief

    Lubricates
    & Refreshes

    STERILE
    0.28 FL OZ
    (8mL)

    PRINCIPAL DISPLAY PANEL - 8 mL Bottle Blister Pack
  • 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:52904-968(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
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    boric acid (UNII: R57ZHV85D4)  
    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:52904-968-031 in 1 BLISTER PACK04/27/2020
    18 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 finalpart34904/27/2020
    Labeler - Select Corporation (053805599)
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