Active Ingredient & Purpose
DRUG FACTS
Active ingredient
Sodium chloride 5%
Sodium Chloride Hypertonicity Ophthalmic Solution, 5% Solution/ Drops
FDA Label NDC 69618-077
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboritories Llc for the product Sodium Chloride Hypertonicity Ophthalmic Solution, 5% (NDC 69618-077). 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, otc - purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hypertonicity agent
Use
temporary relief of corneal edema
Warnings
For external use only
Save box for complete information
When Using This Product
When using this product
- keep tightly closed
- to avoid contamination, do not touch tip of container to any surface
- replace cap after use
- this product may cause temporary burning and irritation on being instilled into the eye.
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
- you experience eye pain
- changes in vision
- continued redness or irritation of the eye
- condition worsens or persists
Keep Out Of Reach Of Children
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 doctor.
Other Information
Other information
- replace cap after using, and keep tightly closed
- store upright at 15–30 °C (59–86 °F)
- remove contact lenses before using
Inactive Ingredient
Boric Acid, Hypromellose Methylparaben, Propylene Glycol, Proplyparaben, purified water and sodium Borate, Sodium Hydroxide, and/or Hydrochloric Acid maybe added to adjust pH.
Questions Or Comments?
Questions or comments?
Call 1-516-341-0666
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Package Label.Principal Display Panel
NDC 696180-077-55
Reliable 1 Laboratories
Temporary relief of corneal edema
Compare to Muro 128® active ingredient*
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%
Sterile
0.5 fl oz (15mL)
*This product is not manufactured by Bausch & Lomb, the owner of the registered trademark Muro 128®
Distributed by
Reliable 1 Laboratories LLC
Valley Stream, NY 11580
Reliable1labs.com
* Please review the disclaimer below.
