VISINE TIRED EYE DRY EYE RELIEF (GLYCERIN, HYPROMELLOSES, AND POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]

VISINE TIRED EYE DRY EYE RELIEF (GLYCERIN, HYPROMELLOSES, AND POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]
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NDC 69968-0024-5
Set ID 45972b04-b7eb-4d5e-97d9-5d6dae6e5ecf
Generic Name
Product Class
Product Number
Application Number PART349
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Glycerin 0.2%Lubricant
    Hypromellose 0.36%Lubricant
    Polyethylene glycol 400 1%Lubricant
  • Use

    • for the temporary relief of burning, irritation , and discomfort due to dryness of the eye or exposure to wind or sun
    • 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

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

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

    Ascorbic Acid, Boric Acid, Dextrose, Glycine, Magnesium Chloride, Polyquaternium-42, Potassium Chloride, Purified Water, Sodium Borate, Sodium Chloride, 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

    NEW
    Sterile
    Visine®

    TIRED
    EYE
    DRY EYE
    Relief
    LUBRICANT EYE DROPS

    Gentle
    PUR®
    TECHNOLOGY

    Soothes
    + revives
    overworked
    eyes from
    screen time
    IRRITATION

    ½ FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VISINE TIRED EYE DRY EYE RELIEF 
    glycerin, hypromelloses, and polyethylene glycol 400 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0024
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2 mg  in 1 mL
    Hypromellose, Unspecified (UNII: 3NXW29V3WO) (Hypromellose, Unspecified - UNII:3NXW29V3WO) Hypromellose, Unspecified3.6 mg  in 1 mL
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ, Polyethylene Glycol, Unspecified - UNII:3WJQ0SDW1A) Polyethylene Glycol 40010 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Boric Acid (UNII: R57ZHV85D4)  
    Dextrose, Unspecified Form (UNII: IY9XDZ35W2)  
    Glycine (UNII: TE7660XO1C)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Polixetonium Chloride (UNII: RNW5AM67C0)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    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:69968-0024-51 in 1 CARTON02/05/201609/30/2021
    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 FINALpart34902/05/201609/30/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)

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