Visine ®

Visine ®
SPL v1
SPL
SPL Set ID 0f50bcc8-3658-8c2c-e063-6294a90a8e13
Route
OPHTHALMIC
Published
Effective Date 2022-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.5 mg) Polyethylene Glycol 400 (10 mg)
Inactive Ingredients
Boric Acid Hypromellose, Unspecified Sodium Citrate, Unspecified Form Potassium Chloride Water Sodium Phosphate, Dibasic, Anhydrous Ascorbic Acid Magnesium Chloride Sodium Lactate Polixetonium Chloride Dextrose, Unspecified Form Glycerin Glycine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-26

Description

​Active ingredients Polyethylene glycol 400 1% Tetrahydrozoline HCl 0.05%

Purpose

​Purpose Lubricant Redness reliever


Medication Information

Purpose

​Purpose

Lubricant

Redness reliever

Description

​Active ingredients Polyethylene glycol 400 1% Tetrahydrozoline HCl 0.05%

Uses

​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
Warnings

For external use only.

Visine ®

[CVP ® Health logo]

VISINE ®

RED EYE

HYDRATING

COMFORT

LUBRICAN/REDNESS RELIEVER EYE DROPS

WORKS

IN 30

SECONDS

Redness +

Irritation

Relief

Lubricates

& Refreshes

STERILE

0.8 FL OZ

(8mL)

Directions

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?

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)

Active Ingredients

​Active ingredients

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

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

Ask A Doctor Before Use

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

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
If Pregnant Or Breast Feeding

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

Keep Out of Reach of Children.

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


Structured Label Content

Uses

​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
Purpose

​Purpose

Lubricant

Redness reliever

Warnings

For external use only.

Visine ®

[CVP ® Health logo]

VISINE ®

RED EYE

HYDRATING

COMFORT

LUBRICAN/REDNESS RELIEVER EYE DROPS

WORKS

IN 30

SECONDS

Redness +

Irritation

Relief

Lubricates

& Refreshes

STERILE

0.8 FL OZ

(8mL)

Directions

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?

Questions? call toll-free

888-734-7648 or 215-273-8755 (collect)

Other Information (Other information)

Other information

Store at 20° to 25°C (68° to 77°F)

Active Ingredients (Active ingredients)

​Active ingredients

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Inactive Ingredients (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

Ask A Doctor Before Use (Ask a doctor before use)

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

When Using This Product (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)

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
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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