Visine®

Drug Facts

Composition & Product

Active Ingredients

Tetrahydrozoline (0.5 mg) Polyethylene Glycol 400 (10 mg)

Inactive Ingredients

Ascorbic Acid Boric Acid Dextrose, Unspecified Form Glycerin Glycine Hypromellose, Unspecified Magnesium Chloride Polixetonium Chloride Potassium Chloride Water Sodium Citrate, Unspecified Form Sodium Lactate Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-04-27

Medication Information

Description

Drug Facts

Uses

for the relief of redness of the eye due to minor eye irritations
for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
for use as a protectant against further irritation or to relieve dryness of the eye

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients	Purpose
Polyethylene glycol 400 1%	Lubricant
Tetrahydrozoline HCl 0.05%	Redness reliever

Warnings

For external use only.

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

Questions?

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

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

When Using This Product

pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using
replace cap after each use
do not use if this solution changes color or becomes cloudy
do not touch tip of container to any surface to avoid contamination

Stop Use and Ask A Doctor If

you feel eye pain
redness or irritation of the eye lasts
changes in vision occur
condition worsens or lasts more than 72 hours

Principal Display Panel 8 Ml Bottle Blister Pack

VISINE_®

RED EYE

HYDRATING

COMFORT

LUBRICANT/REDNESS RELIEVER EYE DROPS

WORKS

IN 30

SECONDS

Redness +

Irritation

Relief

Lubricates

& Refreshes

STERILE

0.28 FL OZ

(8mL)

Structured Label Content

Uses

for the relief of redness of the eye due to minor eye irritations
for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
for use as a protectant against further irritation or to relieve dryness of the eye

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients	Purpose
Polyethylene glycol 400 1%	Lubricant
Tetrahydrozoline HCl 0.05%	Redness reliever

Warnings

For external use only.

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

Questions?

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

Other Information (Other information)

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

When Using This Product (When using this product)

pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using
replace cap after each use
do not use if this solution changes color or becomes cloudy
do not touch tip of container to any surface to avoid contamination

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you feel eye pain
redness or irritation of the eye lasts
changes in vision occur
condition worsens or lasts more than 72 hours

Principal Display Panel 8 Ml Bottle Blister Pack (PRINCIPAL DISPLAY PANEL - 8 mL Bottle Blister Pack)

VISINE_®

RED EYE

HYDRATING

COMFORT

LUBRICANT/REDNESS RELIEVER EYE DROPS

WORKS

IN 30

SECONDS

Redness +

Irritation

Relief

Lubricates

& Refreshes

STERILE

0.28 FL OZ

(8mL)

Advanced Ingredient Data

[{"name": "tetrahydrozoline", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "polyethylene glycol 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "boric acid", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "dextrose, unspecified form", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "glycine", "unii": "TE7660XO1C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium chloride", "unii": "02F3473H9O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "polixetonium chloride", "unii": "RNW5AM67C0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "potassium chloride", "unii": "660YQ98I10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium citrate, unspecified form", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium lactate", "unii": "TU7HW0W0QT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium phosphate, dibasic, anhydrous", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of redness of the eye due to minor eye irritations for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50569-3": "Ask a doctor before use if you have narrow angle glaucoma.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients Purpose Polyethylene glycol 400 1% Lubricant Tetrahydrozoline HCl 0.05% Redness reliever", "Warnings": "For external use only.", "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", "Questions?": "call toll-free 888-734-7648 or 215-273-8755 (collect)", "Other information": "Store at 20° to 25°C (68° to 77°F)", "Inactive ingredients": "ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic", "When using this product": "pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using replace cap after each use do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination", "Stop use and ask a doctor if": "you feel eye pain redness or irritation of the eye lasts changes in vision occur condition worsens or lasts more than 72 hours", "PRINCIPAL DISPLAY PANEL - 8 mL Bottle Blister Pack": "VISINE ® RED EYE HYDRATING COMFORT LUBRICANT/REDNESS RELIEVER EYE DROPS WORKS IN 30 SECONDS Redness + Irritation Relief Lubricates & Refreshes STERILE 0.28 FL OZ (8mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information