Label: VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops

  • NDC Code(s): 42002-203-02, 42002-203-35
  • 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 September 22, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    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

    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • Other information

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

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

  • Questions?

    call toll-free 888-734-7648 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Dist: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman, NJ 08558 USA

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Sterile
    Visine®

    ORIGINAL
    Redness Relief
    TETRAHYDROZOLINE HCl
    REDNESS RELIEVER EYE DROPS

    Gets the
    Red Out®

    Fast-acting
    formula

    1/2 FL OZ (15mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VISINE ORIGINAL   REDNESS RELIEF
    tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-203
    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
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Boric Acid (UNII: R57ZHV85D4)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42002-203-021 in 1 CARTON10/01/200909/30/2022
    115 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    2NDC:42002-203-351 in 1 CARTON10/01/200908/31/2016
    219 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 FINALpart34910/01/200909/30/2022
    Labeler - Johnson & Johnson Consumer Inc. (002347102)