FDA Label for Topcare Eye Drops
View Indications, Usage & Precautions
Topcare Eye Drops Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates 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 (In Each Single-Use Container)
Carboxymethylcellulose sodium 0.5%
Purpose
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
Warnings
For external use only
Do Not Use
if solution changes color or becomes cloudy
When Using This Product
to avoid contamination
• do not touch tip of container to any surface• do not reuse• once opened, discard• do not touch unit-dose tip to eye
Stop Use And Ask A Doctor If
• you experience eye pain• changes in vision occur• redness or irritation of the eye continues• redness or irritation of the eye worsens or persists for more than 72 hours
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• to open, twist and pull tab to remove• instill 1 or 2 drops in the affected eye(s) as needed and discard container
Other Information
• store at 20-25°C (68-77°F)• RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients
calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium lactate solution, water for injection. May also contain sodium hydroxide and/or hydrochloric acid to adjust pH.
Questions Or Comments?
1-888-423-0139
Package/Label Principal Display Panel
COMPARE TO REFRESH PLUS® LUBRICANT EYE DROPS ACTIVE INGREDIENT
SENSITIVE PRESERVATIVE-FREE
Lubricating Plus Lubricant Eye Drops
CARBOXYMETHYLCELLULOSE SODIUM 0.5%
Moisturizing Relief for Dry Eyes
Long-Lasting Formula
Actual Size
30 SINGLE-USE CONTAINERS
0.01 FL OZ (0.4 mL) EACH Sterile
* Please review the disclaimer below.