Otc - Active Ingredient
Active ingredients
Carboxymethylcellulose sodium 0.5%
Equate Restore Plus Lubricant Eye Drops Solution/ Drops
FDA Label NDC 49035-389
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walmart, Inc. for the product Equate Restore Plus Lubricant Eye Drops (NDC 49035-389). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Carboxymethylcellulose sodium.....Lubricant
Indications & Usage
Uses
- for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
- may be used as a protectant against further irritation
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use this product if
- solution changes color or becomes cloudy
Otc - When Using
When using this product
- do not reuse
- once opened, discard
- to avoid contamination, do not touch tip of container to any surface
- do not touch unit-dose tip to eye
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Dosage & Administration
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
Other Safety Information
Other information
- store at 15°-25°C (59°-77°F)
- use only if single-use container is intact
- use before expiration date marked on container
- RETAIN THIS CARTON FOR FUTURE REFERENCE
Inactive Ingredient
Inactive ingredients calcium chloride, **hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate. **May contain these ingredients to adjust pH.
Otc - Questions
Questions or comments? Call X-XXX-XXX-XXXX DAYS & TIMES & ZONE (or specific to customer’s labeling guide)
* Please review the disclaimer below.
