Sodium Chloride
FDA Label NDC 0363-9050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Sodium Chloride (NDC 0363-9050). 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 other, active ingredient, purpose, use, warnings, otc - stop use, otc - 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

Other

Drug Facts

Active Ingredient

Sodium Chloride 5%

Purpose

Hypertonicity Agent

Use

For temporary relief of corneal edema.

Warnings

  • do not use this product except under the advice and supervision of a doctor
  • do not use if cap skirt is dislodged from tube
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
  • may cause temporary burning and irritation upon application into the eye

Otc - Stop Use

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision occur
  • continued redness or irritation of the eye
  • the condition worsens or persists for more than 72 hours

Otc - 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

Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.

Other Information

  • store at 20° to 25° C (68° to 77°F) [see USP Controlled Room Temperature].
  • store away from heat
  • protect from freezing
  • keep tightly closed
  • see crimp for Lot Number and Expiration Date
  • Retain this carton for future reference

Inactive Ingredients

  • Mineral Oil, Modified Lanolin, Water for Injection and White Petrolatum.

Questions Or Comments?

1-800-932-5676

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

STERILE Well at

Sodium Chloride Walgreens

Ophthalmic Ointment NDC 0363-9050-00

USP, 5% NET WT 3.5 g (1/8 oz.)

Hypertonicity Eye Ointment

FOR OPHTHALMIC USE ONLY

Principal Display Panel Text for Carton Label:

STERILE Well at

Walgreens NDC 0363-9050-00

WALGREENS PHARMACIST RECOMMENDED≠

Sodium Chloride

Ophthalmic Ointment

USP, 5%

Hypertonicity Eye Ointment

Compare to Muro 128®

Ointment active ingredient#

NET WT 3.5 g (1/8 OZ)

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