Sodium Chloride Hypertonicity Ophthalmic Ointment
FDA Label NDC 0536-1253

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 Chloride Hypertonicity Ophthalmic (NDC 0536-1253). 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

Active Ingredient

Sodium chloride 50 mg (5%)

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

When using this product

  • ▪it may cause temporary burning and irritation
  • ▪replace cap after use
  • ▪to avoid contamination do not touch tip of container to any surface

    • 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

  • ▪pull down the lower lid of the affected eye
  • ▪apply a small amount (1/4 inch) of ointment to the inside of eyelid
  • ▪apply every 3 or 4 hours or as directed by a doctor

Other Information

  • ▪store at 15° - 25°C (59° - 77°F)
  • ▪keep tightly closed
  • ▪DO NOT FREEZE
  • ▪see crimp of tube or carton for Lot Number and Expiration Date
  • ▪do not use if difficult to dispense or visible particles are seen in the product
  • ▪serious side effects associated with use of the product may be reported to the phone number below

Inactive Ingredients

lanolin, mineral oil, purified water, white petrolatum

Questions [Phone Icon]

Call 1-800-645-2158

Package/Label Principal Display Panel Carton

Rugby®

NDC 0536-1253-91

Sodium Chloride Hypertonicity
Ophthalmic Ointment, 5%

  •  STERILE NET WT. 1/8 OZ. (3.5 G)
    • Carton (Image 01)

    Carton (Image 01)

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