Label: VISINE RED EYE COMFORT- tetrahydrozoline hydrochloride solution/ drops

  • NDC Code(s): 69968-0355-1
  • 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 February 5, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tetrahydrozoline HCl 0.05%

  • Purpose

    Redness reliever

  • Use

    • for the relief of redness of the eye due to minor eye irritations
  • 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, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium borate, 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
    COMFORT

    REDNESS RELIEVER EYE DROPS

    FAST ACTING
    Redness Relief

    STERILE
    1/2 FL OZ (15mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VISINE RED EYE COMFORT 
    tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0355
    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
    Inactive Ingredients
    Ingredient NameStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Boric Acid (UNII: R57ZHV85D4)  
    Dextrose, Unspecified Form (UNII: IY9XDZ35W2)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycine (UNII: TE7660XO1C)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Polixetonium Chloride (UNII: RNW5AM67C0)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    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:69968-0355-11 in 1 CARTON04/27/2020
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34904/27/2020
    Labeler - Johnson & Johnson Consumer Inc. (002347102)