FDA Label for Visine Red Eye Total Comfort And Tears Dry Eye Relief
View Indications, Usage & Precautions
Visine Red Eye Total Comfort And Tears Dry Eye Relief Product Label
The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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VISINE ® Red Eye Total Comfort Multi-Symptom
Drug Facts
VISINE ® Dry Eye Relief
Drug Facts
Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558
Active Ingredient
Polyethylene glycol 400 1%
Tetrahydrozoline HCl 0.05%
Zinc sulfate 0.25%
Polyethylene glycol 400 1%
Purpose
Lubricant
Redness reliever
Astringent
Lubricant
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
- for the temporary relief of burning and irritation due to dryness of the eye
- for protection against further irritation
Warnings
For external use only
For external use only
Otc - Ask Doctor
Ask a doctor before use if you have narrow angle glaucoma.
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
• 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
• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens or lasts more than 72 hours
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
• adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) as needed
• children under 6 years of age: consult a doctor
Other Information
Store at 20° to 25°C (68° to 77°F)
Store at room temperature
Inactive Ingredients
benzalkonium chloride, boric acid, edetate disodium, glycerin, hypromellose, purified water, sodium chloride, sodium citrate
ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycerin, glycine, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate
Questions?
call toll-free 888-734-7648 or 215-273-8755 (collect)
call toll-free 888-734-7648 or 215-273-8755 (collect)
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)
* Please review the disclaimer below.