VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF- tetrahydrozoline hcl, polyethylene glycol 400, zinc sulfate kit

Visine Red Eye Total Comfort and Tears Dry Eye Relief by

Drug Labeling and Warnings

Visine Red Eye Total Comfort and Tears Dry Eye Relief by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

VISINE ® Red Eye Total Comfort Multi-Symptom

Drug Facts

Active ingredient

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purpose

Lubricant

Redness reliever

Astringent

Uses

• for the temporary relief of discomfort and redness of the eye due to minor eye irritations
• relieves dryness of the eye
• for the temporary relief of burning and irritation due to exposure to wind or sun
• for protection against further irritation

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma.

When using this product

some users may experience a brief tingling sensation
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

benzalkonium chloride, boric acid, edetate disodium, glycerin, hypromellose, purified water, sodium chloride, sodium citrate

Questions?

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

SPL UNCLASSIFIED SECTION

VISINE ® Dry Eye Relief

Drug Facts

Active ingredient

Polyethylene glycol 400 1%

Purpose

Lubricant

Uses

• for the temporary relief of burning and irritation due to dryness of the eye
• for protection against further irritation

Warnings

For external use only

When using this product

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) as needed

children under 6 years of age: consult a doctor

Other information

Store at room temperature

Inactive ingredients

ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycerin, glycine, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

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 - Kit Package

VALUE

MULTI-PACK

VISINE ®

RED EYE

TOTAL COMFORT

MULTI-SYMPTOM

ASTRINGENT / LUBRICANT / REDNESS RELIEVER EYE DROPS

UP TO

10 HRS

COMFORT

ALL-IN ONE RELIEF

From Red, Burning,

Watery, Itchy, Dry, Gritty,

Irritated Eyes

Protects Against

Further Irritation

STERILE

Use products only

as directed.

DRY EYE

RELIEF

LUBRICANT EYE DROPS

MOISTURIZES +

SOOTHES DRY,

GRITTY EYES

Designed to Work

Like Real

Tears

1 BOTTLE: VISINE®

RED EYE TOTAL COMFORT MULTI-SYMPTOM

½ FL OZ (15 mL)

1 BOTTLE: VISINE® DRY EYE RELIEF ½ FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF 
tetrahydrozoline hcl, polyethylene glycol 400, zinc sulfate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0844

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0844-9	1 in 1 PACKAGE	06/08/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DROPPER	15 mL
Part 2	1 BOTTLE, DROPPER	15 mL

Part 1 of 2

VISINE RED EYE TOTAL COMFORT MULTI-SYMPTOM 
tetrahydrozoline hydrochloride, polyethylene glycol 400, and zinc sulfate, unspecified form solution/ drops

Product Information
Item Code (Source)	NDC: 69968-0360
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE, UNSPECIFIED FORM	2.5 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0360-1	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	04/27/2020

Part 2 of 2

VISINE DRY EYE RELIEF 
polyethylene glycol 400 solution/ drops

Product Information
Item Code (Source)	NDC: 69968-0363
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCINE (UNII: TE7660XO1C)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
BORIC ACID (UNII: R57ZHV85D4)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0363-1	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	06/08/2020

Labeler - Kenvue Brands LLC (118772437)