Sodium Chloride Ophthalmic Solution, Usp

Sodium Chloride Ophthalmic Solution, Usp
SPL v8
SPL
SPL Set ID ab12c419-4b1a-4119-9e23-76ce7a89d1a7
Route
OPHTHALMIC
Published
Effective Date 2022-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (50 mg)
Inactive Ingredients
Boric Acid Hypromelloses Propylene Glycol Sodium Borate Sodium Hydroxide Hydrochloric Acid Water Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1998-04-01
Description

Drug Facts

Purpose

Hypertonicity Agent

Medication Information

Purpose

Hypertonicity Agent

Description

Drug Facts

Use
  • for temporary relief of corneal edema.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • you experience eye pain.
  • you experience changes in vision.
  • redness or irritation of the eye continues
  • condition worsens or persists.
Section 50567-7

When using this product

  • temporary burning and irritation upon being instilled into eye may occur.
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use
Section 50570-1

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.
Section 51945-4

Principal Display Panel Text for Container Label:

NDC 17478-623-12

5%

SODIUM

CHLORIDE

Ophthalmic

Solution, USP

Hypertonicity

Eye Drops

15 mL (0.5 fl. oz.) Sterile

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Active Ingredient

Sodium Chloride 5%

Other Information
  • Store at 20° to 25°C (68° to77°F) [see USP Controlled Room Temperature].
  • Keep tightly closed.
Inactive Ingredients

Boric Acid, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylparaben 0.1 mg (0.01%), Propylene Glycol, Sodium Borate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (6.0 to 8.0), and Water for Injection.

Structured Label Content

Use
  • for temporary relief of corneal edema.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you experience eye pain.
  • you experience changes in vision.
  • redness or irritation of the eye continues
  • condition worsens or persists.
Section 50567-7 (50567-7)

When using this product

  • temporary burning and irritation upon being instilled into eye may occur.
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use
Section 50570-1 (50570-1)

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.
Section 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

NDC 17478-623-12

5%

SODIUM

CHLORIDE

Ophthalmic

Solution, USP

Hypertonicity

Eye Drops

15 mL (0.5 fl. oz.) Sterile

Purpose

Hypertonicity Agent

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Active Ingredient (Active ingredient)

Sodium Chloride 5%

Other Information (Other information)
  • Store at 20° to 25°C (68° to77°F) [see USP Controlled Room Temperature].
  • Keep tightly closed.
Inactive Ingredients (Inactive ingredients)

Boric Acid, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylparaben 0.1 mg (0.01%), Propylene Glycol, Sodium Borate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (6.0 to 8.0), and Water for Injection.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:15.817630 · Updated: 2026-03-14T23:00:38.812142