Visine ®

Visine ®
SPL v4
SPL
SPL Set ID d7abd7cb-e094-481f-bea5-a5983e2c9ef4
Route
OPHTHALMIC
Published
Effective Date 2020-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.5 mg)
Inactive Ingredients
Ascorbic Acid Boric Acid Dextrose, Unspecified Form Glycerin Glycine Magnesium Chloride Polixetonium Chloride Potassium Chloride Water Sodium Borate Sodium Citrate, Unspecified Form Sodium Lactate Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-27

Description

Drug Facts

Purpose

Redness reliever


Medication Information

Purpose

Redness reliever

Description

Drug Facts

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

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)

Active Ingredient

Tetrahydrozoline HCl 0.05%

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

ascorbic acid, boric acid, dextrose, glycerin, glycine, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium borate, 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
  • 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
Principal Display Panel 15 Ml Bottle Carton

VISINE ®

RED EYE

COMFORT


REDNESS RELIEVER EYE DROPS

FAST ACTING

Redness Relief

STERILE

1/2 FL OZ (15mL)


Structured Label Content

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

Purpose

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)

Active Ingredient (Active ingredient)

Tetrahydrozoline HCl 0.05%

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, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium borate, 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
  • 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 (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
Principal Display Panel 15 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton)

VISINE ®

RED EYE

COMFORT


REDNESS RELIEVER EYE DROPS

FAST ACTING

Redness Relief

STERILE

1/2 FL OZ (15mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)