Active Ingredient
Sodium chloride 5%
Sodium Chloride Hypertonicity Solution
FDA Label NDC 69842-284
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Sodium Chloride Hypertonicity (NDC 69842-284). 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, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hypertonicity agent
Uses
temporary relief of corneal edema
Warnings
For external use only
Do not use
▪ except under the advice and supervision of a doctor
▪ if solution changes color or becomes cloudy
When using this product
▪ it may cause temporary burning and irritation
▪ to avoid contamination do not touch tip of container to any surface
▪ replace cap after use
Stop use and ask a doctor if
▪ condition worsens or persists for more than 72 hours
▪ you experience eye pain, changes in vision, continued redness or irritation of the eye
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.
Other Information
▪ store upright at 15°-25°C (59°-77°F)
▪ keep tightly closed
▪ serious side effects associated with use of the product may be reported to the phone number provided below
Inactive Ingredients
boric acid, hypromellose, propylene glycol, purified water, sodium borate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVES ADDED: methylparaben 0.023%, propylparaben 0.01%.
Questions
[phone icon] Call 1-866-767-9161
Package/Label Principal Display Panel
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Compare to the
active ingredient
in Muro 128®*
NDC 69842-284-15
Sodium
Chloride
Hypertonicity
ophthalmic solution, 5%
Temporary relief
of corneal edema
Actual Size Bottle
on Side Panel
STERILE
15 mL (0.5 FL OZ)
Carton15ml (Image 01)
* Please review the disclaimer below.
