FDA Label for Lubricating Eye Drops

View Indications, Usage & Precautions

Lubricating Eye Drops Product Label

The following document was submitted to the FDA by the labeler of this product A2a Integrated Pharmaceuticals, Llc. 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 Ingredient                                                                    Purpose



Carboxymethylcellulose sodium 0.5%------------------------- Eye lubricant


Uses



  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • May be used as a protectant against further irritation of the eye.

Warnings



For external use only

• Do not use if solution changes color or becomes cloudy.

When using this product

to avoid contamination, do no touch tip of container to any surface. Do not reuse. Once open, discard.

Do not touch unit dose tip to eye.

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours.


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



■ TWIST AND REMOVE TAB.

■ Place 1 or 2 drops in the affected eye(s) as needed for relief and discard container.
■ If used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions.


Inactive Ingredients



Calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide*, and sodium
lactate.*May or may not contain this ingredient to adjust pH.


Other Information



■ Use only if single-use container is intact.
■ Use before expiration date marked on container.
■ RETAIN THIS FOIL FOR FUTURE REFERENCE.


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* Please review the disclaimer below.