Active Ingredient
Carboxymethylcellulose sodium 0.5%
Refresh Plus Solution/ Drops
FDA Label NDC 0023-0403
11 label sections · Submitted to the FDA by Allergan, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allergan, Inc. for the product Refresh Plus (NDC 0023-0403). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
- 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.
- If solution changes color or becomes cloudy, do not 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.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
To open, TWIST AND PULL TAB TO REMOVE.
Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
*Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.
Other Information
- Use only if single-use container is intact.
- Use before expiration date marked on container.
- Store at 59°-77°F (15°-25°C).
- RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients
Calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; purified water; sodium chloride; and sodium lactate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).
Questions Or Comments?
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refresheyedrops.com
v2.0DFL0403
Principal Display Panel
NDC 0023-0403-30
PRESERVATIVE -FREE
Refresh
PLUS®
Lubricant Eye Drops
Original Strength
Dry Eye Relief
30 Vials 0.01 fl oz (0.4 mL) each Sterile
Principal Display Panelndc 0023-0403-30preservative -freerefreshplus®lubricant Eye Dropsoriginal Strengthdry Eye Relief30 Vials 0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Plus 02)
NDC 0023-0403-50
VALUE SIZE 50 Vials
PRESERVATIVE -FREE
Refresh
Plus®
Lubricant Eye Drops
Original Strength
Dry Eye Relief
50 Vials
0.01 fl oz (0.4 mL) each Sterile
Principal Display Panelndc 0023-0403-50value Size 50 Vialspreservative -freerefreshplus®lubricant Eye Dropsoriginal Strengthdry Eye Relief50 Vials 0.01 Fl Oz (0.4 mL) Each Sterile (Refresh Plus 03)
NDC 0023-0403-70
VALUE SIZE 70 Vials
PRESERVATIVE -FREE
Refresh
Plus®
Lubricant Eye Drops
Original Strength
Dry Eye Relief
70 Vials 0.01 fl oz (0.4mL) each Sterile
Principal Display Panelndc 0023-0403-70value Size 70 Vialspreservative -freerefreshplus®lubricant Eye Dropsoriginal Strength Dry Eye Relief 70 Vials 0.01 Fl Oz (0.4ml) Each Sterile (Refresh Plus 04)
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