Sodium Chlorode Hypertonicity Ophthalmic Solution
FDA Label NDC 0536-1254

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Sodium Chlorode Hypertonicity Ophthalmic Solution (NDC 0536-1254). 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 ingredients, 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

Active Ingredients

Sodium chloride 5%

Purpose

Hypertonicity agent

Uses

temporary relief of corneal edema

Warnings

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 1-800-645-2158

Package/Label Principal Display Panel – Carton

Carton (Image 01)

Carton (Image 01)

NDC 0536-1254-94

Rugby®

Sodium Chloride
Hypertonicity
Ophthalmic
Solution, 5%

STERILE

1/2 FL. OZ. (15 mL)

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