FDA Label for Dry Eyes

View Indications, Usage & Precautions

Dry Eyes Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.

Active Ingredients



Mineral oil 15%
White petrolatum 83%


Purpose



Lubricant


Uses



  • to prevent further irritation
  • to relieve dryness of the eye

Warnings



When using this product  

  • replace cap after use
  • do not touch tip of container to any surface to avoid contamination
  • Stop use and ask a doctor if

    • condition worsens or persists for more than 72 hours
    • you experience eye pain, changes in vision, continued redness or irritation of the eye

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  •  pull down the lower lid of the affected eye(s)
  •  apply a small amount (1/4 inch) of ointment to the inside of eyelid
  •  apply one or more times daily or as directed by a doctor

Other Information



  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed
  • see crimp of tube or carton for Lot Number and Expiration Date
  •  


Inactive Ingredient



lanolin oil


Questions?



Serious side effects associated with use of this product may be reported to

1-800-323-0000

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.


Package/Label Principal Display Panel



NDC 37205-134-79

LEADER®

Compare to Refresh P.M. active ingredient*

Dry Eyes

Lubricant Eye Ointment
(Sterile)

Preservative Free

Prevents irritation & relieves dryness of the eye

SATISFACTION GUARANTEED Net wt. 1/8 oz. (3.5 g)


* Please review the disclaimer below.