Label: VISINE ADVANCED RELIEF- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit
VISINE ADVANCED RELIEF- dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops

  • NDC Code(s): 42002-202-01, 42002-202-02, 42002-202-03, 42002-202-04, view more
    42002-202-05, 42002-202-08, 42002-202-35, 42002-214-45, 42002-215-25
  • 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 6, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Dextran 70 0.1%Lubricant
    Polyethylene glycol 400 1%Lubricant
    Povidone 1%Lubricant
    Tetrahydrozoline HCl 0.05%Redness reliever
  • Uses

    • for the relief of redness of the eye due to minor eye irritations
    • 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

    • 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, and sodium chloride

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Sterile
    Visine®

    ADVANCED
    Redness +
    Irritation Relief
    LUBRICANT / REDNESS
    RELIEVER EYE DROPS

    Gets the
    Red Out® +
    moisturizes

    Hydrating
    moisturizers
    soothe,
    refresh + cool

    1/2 FL OZ (15mL)

    Principal Display Panel - 15 mL Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 8 mL Bottle Carton

    Sterile
    Visine®

    ADVANCED
    Redness +
    Irritation Relief
    LUBRICANT / REDNESS
    RELIEVER EYE DROPS

    Gets the
    Red Out® +
    moisturizes

    Hydrating
    moisturizers
    soothe,
    refresh + cool

    0.28 FL OZ (8mL)

    Principal Display Panel - 8 mL Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    Sterile
    Visine®

    ADVANCED
    Redness +
    Irritation Relief
    LUBRICANT / REDNESS
    RELIEVER EYE DROPS

    Gets the
    Red Out® +
    moisturizes

    Hydrating
    moisturizers
    soothe,
    refresh + cool

    1 FL OZ (30mL)

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VISINE ADVANCED RELIEF  
    dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-214
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42002-214-451 in 1 PACKAGE, COMBINATION06/03/201103/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DROPPER 30 mL
    Part 22 BOTTLE, DROPPER 30 mL
    Part 1 of 2
    VISINE ADVANCED RELIEF  
    dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 701 mg  in 1 mL
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 40010 mg  in 1 mL
    Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E) Povidone, Unspecified10 mg  in 1 mL
    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
    11 in 1 CARTON
    130 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 FINALpart34906/03/2011
    Part 2 of 2
    VISINE ADVANCED RELIEF  
    dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 701 mg  in 1 mL
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 40010 mg  in 1 mL
    Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E) Povidone, Unspecified10 mg  in 1 mL
    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
    12 in 1 CARTON
    11 in 1 CARTON
    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 finalpart34906/03/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/03/201103/01/2018
    VISINE ADVANCED RELIEF  
    dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-215
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42002-215-251 in 1 PACKAGE, COMBINATION06/03/201103/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BOTTLE, DROPPER 60 mL
    Part 22 BOTTLE, DROPPER 16 mL
    Part 1 of 2
    VISINE ADVANCED RELIEF  
    dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 701 mg  in 1 mL
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 40010 mg  in 1 mL
    Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E) Povidone, Unspecified10 mg  in 1 mL
    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
    12 in 1 CARTON
    11 in 1 CARTON
    130 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 FINALpart34906/03/2011
    Part 2 of 2
    VISINE ADVANCED RELIEF  
    dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 701 mg  in 1 mL
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 40010 mg  in 1 mL
    Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E) Povidone, Unspecified10 mg  in 1 mL
    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
    12 in 1 CARTON
    11 in 1 CARTON
    18 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 finalpart34906/03/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/03/201103/01/2018
    VISINE ADVANCED RELIEF 
    dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-202
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 701 mg  in 1 mL
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 40010 mg  in 1 mL
    Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E) Povidone, Unspecified10 mg  in 1 mL
    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:42002-202-011 in 1 CARTON05/15/201111/30/2017
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:42002-202-022 in 1 PACKAGE, COMBINATION05/15/201111/30/2017
    21 in 1 CARTON
    230 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:42002-202-051 in 1 CARTON05/15/201108/31/2021
    315 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4NDC:42002-202-081 in 1 CARTON05/15/201106/01/2021
    48 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    5NDC:42002-202-351 in 1 CARTON05/15/201107/31/2021
    519 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    6NDC:42002-202-031 in 1 PACKAGE05/15/201111/30/2017
    630 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    7NDC:42002-202-041 in 1 BLISTER PACK05/15/201105/01/2020
    78 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34905/15/201108/31/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)