visine red eye total comfort and tears dry eye relief

visine red eye total comfort and tears dry eye relief
SPL v2
SPL
SPL Set ID 0bc0d6e7-9195-db6b-e063-6294a90aef04
Route
ophthalmic
Published
Effective Date 2023-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tetrahydrozoline (0.5 mg) zinc cation (2.5 mg) polyethylene glycol 400 (10 mg)
Inactive Ingredients
boric acid sodium citrate edetate disodium hypromelloses water glycerin sodium chloride benzalkonium chloride glycine dextrose sodium phosphate, dibasic, anhydrous potassium chloride magnesium chloride sodium lactate ascorbic acid sodium borate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-06-08

Purpose

Lubricant Redness reliever Astringent

Description

VISINE ® Red Eye Total Comfort Multi-Symptom Drug Facts


Medication Information

Warnings

For external use only

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
Purpose

Lubricant

Redness reliever

Astringent

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

Description

VISINE ® Red Eye Total Comfort Multi-Symptom Drug Facts

Questions?

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

Section 42229-5

VISINE ® Red Eye Total Comfort Multi-Symptom

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.

Active Ingredient

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

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 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)


Structured Label Content

Warnings

For external use only

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
Purpose

Lubricant

Redness reliever

Astringent

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 (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

Questions?

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

Section 42229-5 (42229-5)

VISINE ® Red Eye Total Comfort Multi-Symptom

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.

Active Ingredient (Active ingredient)

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

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 Kit Package (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)


Advanced Ingredient Data


Raw Label Data

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