FDA Label for Family Care Lubricant Single Use Eye

View Indications, Usage & Precautions

Family Care Lubricant Single Use Eye Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corp. 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.

Otc - Active Ingredient



Active ingredient                                                                     Purpose

Carboxymethylcellulose Sodium 0.5%......................................Eye Lubricant


Otc - Purpose



Uses

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

Warnings



Warnings

For external use only

  • To avoid contamination, do not touch tip of container to any surface
  • Do not reuse. Once opened, discard

    • Do not touch unit-dose tip of eye
    • if solution changes color or becomes cloudy, do not use


Otc - Do Not Use



Do not reuse. Once opened, discard

  • Do not touch unit-dose tip of eye
  • if solution changes color or becomes cloudy, do not use

Otc - Stop Use



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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Indications & Usage



Directions

To open, TWIST AND PULL TAB TO REMOVE.  Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

  • If used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions.

Storage And Handling



Other information

  • Use only if single-use container is intact.
  • Use before expiration date marked on container.
  • Store at 59° to 86°F (15° to 30°C)
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredient



calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, and sodium lactate.  May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.


Dosage & Administration



Distributed by:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

MADE IN KOREA


Package Label.Principal Display Panel




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