Visine ®

Visine ®
SPL v4
SPL
SPL Set ID 5747edef-7a87-41d7-9594-6c78508b9ba2
Route
OPHTHALMIC
Published
Effective Date 2020-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.5 mg) Polyethylene Glycol 400 (10 mg) Zinc Cation (2.5 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Edetate Disodium Glycerin Hypromellose, Unspecified Water Sodium Chloride Sodium Citrate, Unspecified Form

Identifiers & Packaging

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

Description

Drug Facts


Medication Information

Description

Drug Facts

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
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
Zinc sulfate 0.25% Astringent
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

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

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
Principal Display Panel 15 Ml Bottle Carton

UP TO 10 HRS COMFORT

VISINE ®

RED EYE

TOTAL COMFORT

MULTI-SYMPTOM


ASTRINGENT /LUBRICANT

REDNESS RELIEVER EYE DROPS

ALL-IN ONE RELIEF

From Red, Burning, Watery,

Itchy, Dry, Gritty, Irritated Eyes

Protects Against

Further Irritation

STERILE

1/2 FL OZ (15 mL)


Structured Label Content

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
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
Zinc sulfate 0.25% Astringent
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)

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

When Using This Product (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 (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)

UP TO 10 HRS COMFORT

VISINE ®

RED EYE

TOTAL COMFORT

MULTI-SYMPTOM


ASTRINGENT /LUBRICANT

REDNESS RELIEVER EYE DROPS

ALL-IN ONE RELIEF

From Red, Burning, Watery,

Itchy, Dry, Gritty, Irritated Eyes

Protects Against

Further Irritation

STERILE

1/2 FL OZ (15 mL)


Advanced Ingredient Data


Raw Label Data

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