FDA Label for Visine Red Eye Hydrating Comfort Eye Drops

View Indications, Usage & Precautions

Visine Red Eye Hydrating Comfort Eye Drops Product Label

The following document was submitted to the FDA by the labeler of this product Select Corporation. 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.

Other



Drug Facts

Product Repackaged and Distributed by:
Select Corporation Carrollton, TX 75007

Distributed by: Johnson & Johnson Consumer Inc.
Skillman, NJ 085598


Otc - Purpose



Active ingredientsPurpose
Polyethylene glycol 400 1%Lubricant
Tetrahydrozoline HCl 0.05%Redness reliever

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.


Otc - Ask Doctor



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


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



  • you feel eye pain
  • redness or irritation of the eye lasts
  • changes in vision occur
  • condition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding



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.


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



ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic


Questions?



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


Principal Display Panel - 8 Ml Bottle Blister Pack



VISINE®

RED EYE
HYDRATING
COMFORT
LUBRICANT/REDNESS RELIEVER EYE DROPS

WORKS
IN 30
SECONDS

Redness +
Irritation
Relief

Lubricates
& Refreshes

STERILE
0.28 FL OZ
(8mL)


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