Sodium Chloride
FDA Label NDC 17238-625

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hub Pharmaceuticals for the product Sodium Chloride (NDC 17238-625). 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 drug facts:, inactive ingredients:, preservative:, directions:, dosage & administration:, indications:, otc - purpose, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts:

Active Ingredient

(each mL contains)

Purpose

Sodium Chloride USP

5% w/v (50mg)

Hypertonicity agent

Preservative:

Methylparaben

USP 0.023% w/v

PropylparabenUSP 0.01% w/v

Directions:

  • To open, twist cap clockwise to puncture sterile seal.
  • Remove cap.
  • Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours as needed or directed by a doctor.

Dosage & Administration:

Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours as needed or directed by a doctor.

Indications:

For the temporaty relief of corneal edema.

Otc - Purpose

For the temporaty relief of corneal edema.

Warnings

External use only

Do Not Use

  • this product except under the advice and supervision of a doctor
  • if imprinted seal is broken or missing
  • if solution changes color or becomes cloudy

    • When using this product:

    • temporoary burning and iritation upon being instilled into eye may occur
    • To avoid contamination, do not touch top of container to any surface
    • Replace cap after using, keep tightly closed

      • In case of accidental ingestion, seek professional help or contact a Poision Control Center immediately.

      Stop use and ask a doctor if:

      • you experience eye pain, changes in vision, continued redness, or irritation of the eye.
      • if the condition worses or persists

User Safety Warnings

save box for complete warnings and instructions

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

If swallowed, get medical help for contact a Poison Control Center immediately.

Storage And Handling

Store at room temperature 15°-30°C (59°-86°F).

Representative Packaging:

Sodium Chloride Solution Label

Sodium Chloride Solution Box

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