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: Johnson & Johnson Consumer Inc.
  • 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 January 3, 2023

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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
    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: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 finalpart34904/27/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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