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

Visine Advanced Relief by

Drug Labeling and Warnings

Visine Advanced Relief by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 - 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 - 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)

INGREDIENTS AND APPEARANCE

VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-214

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-214-45	1 in 1 PACKAGE, COMBINATION	06/03/2011	03/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DROPPER	30 mL
Part 2	2 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 Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68)	Dextran 70	1 mg  in 1 mL
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	10 mg  in 1 mL
Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E)	Povidone, Unspecified	10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D) (Tetrahydrozoline - UNII:S9U025Y077)	Tetrahydrozoline Hydrochloride	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	06/03/2011

Part 2 of 2

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

Product Information
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68)	Dextran 70	1 mg  in 1 mL
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	10 mg  in 1 mL
Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E)	Povidone, Unspecified	10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D) (Tetrahydrozoline - UNII:S9U025Y077)	Tetrahydrozoline Hydrochloride	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/03/2011	03/01/2018

VISINE ADVANCED RELIEF  
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-215

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-215-25	1 in 1 PACKAGE, COMBINATION	06/03/2011	03/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BOTTLE, DROPPER	60 mL
Part 2	2 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 Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68)	Dextran 70	1 mg  in 1 mL
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	10 mg  in 1 mL
Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E)	Povidone, Unspecified	10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D) (Tetrahydrozoline - UNII:S9U025Y077)	Tetrahydrozoline Hydrochloride	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	06/03/2011

Part 2 of 2

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

Product Information
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68)	Dextran 70	1 mg  in 1 mL
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	10 mg  in 1 mL
Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E)	Povidone, Unspecified	10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D) (Tetrahydrozoline - UNII:S9U025Y077)	Tetrahydrozoline Hydrochloride	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
1		1 in 1 CARTON
1		8 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/03/2011	03/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-202
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68)	Dextran 70	1 mg  in 1 mL
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	10 mg  in 1 mL
Povidone, Unspecified (UNII: FZ989GH94E) (Povidone, Unspecified - UNII:FZ989GH94E)	Povidone, Unspecified	10 mg  in 1 mL
Tetrahydrozoline Hydrochloride (UNII: 0YZT43HS7D) (Tetrahydrozoline - UNII:S9U025Y077)	Tetrahydrozoline Hydrochloride	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-202-01	1 in 1 CARTON	05/15/2011	11/30/2017
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 42002-202-02	2 in 1 PACKAGE, COMBINATION	05/15/2011	11/30/2017
2		1 in 1 CARTON
2		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 42002-202-05	1 in 1 CARTON	05/15/2011	08/31/2021
3		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 42002-202-08	1 in 1 CARTON	05/15/2011	06/01/2021
4		8 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
5	NDC: 42002-202-35	1 in 1 CARTON	05/15/2011	07/31/2021
5		19 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
6	NDC: 42002-202-03	1 in 1 PACKAGE	05/15/2011	11/30/2017
6		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
7	NDC: 42002-202-04	1 in 1 BLISTER PACK	05/15/2011	05/01/2020
7		8 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	05/15/2011	08/31/2021

Labeler - Johnson & Johnson Consumer Inc. (002347102)