VISINE ADVANCED RELIEF - dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride 
VISINE ADVANCED RELIEF- dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops 
Johnson & Johnson Consumer Inc.

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.

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Visine®Advanced Relief

Drug Facts

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
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)

Revised: 1/2020
Document Id: a9b72d24-2d8f-4a89-9464-6651803197f7
Set id: a53d1ba2-f42a-40b0-ba37-998b28b51668
Version: 7
Effective Time: 20200106
 
Johnson & Johnson Consumer Inc.