SPL v7
SPL
SPL Set ID 72342206-7b82-46e9-95e0-1e1cea8678a3
Route
OPHTHALMIC
Published
Effective Date 2022-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (50 mg)
Inactive Ingredients
Mineral Oil Lanolin Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-12
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 right away.

Section 50566-9

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
Section 51945-4

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

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
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.

Active Ingredient

Sodium Chloride 5%

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

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 right away.

Section 50566-9 (50566-9)

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
Section 51945-4 (51945-4)

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

Purpose

Hypertonicity Agent

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
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.

Active Ingredient (Active ingredient)

Sodium Chloride 5%

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 (Inactive ingredients)
  • Mineral Oil, Modified Lanolin, Water for Injection and White Petrolatum.
Questions Or Comments? (Questions or comments?)

1-800-932-5676

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:02.823537 · Updated: 2026-03-14T23:00:21.684898