Sodium Chloride

Manufacturer
AACE PHARMACEUTICALS, INC.
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:41:04

Label at a glance#

ProductSodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure11 sections

Dosage and administration

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

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 5%

PURPOSE

OTC - PURPOSE SECTION

Hypertonicity agent

USE

INDICATIONS & USAGE SECTION

For temporary relief of corneal edema.

WARNINGS

WARNINGS SECTION

  • Do not use this product except under the advice and supervision of a doctor.
  • Do not use if bottom ridge of tube cap is exposed.
  • 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

Lanolin, Mineral Oil, Purified Water and White Petrolatum.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC#: 71406-123-35

*Compare to MURO 128 ®

Sodium Chloride Opthalmic Ointment USP, 5%

Hypertonicity Eye Ointment

FOR OPTHALMIC USE ONLY

Net Wt. 3.5 g (1/8 oz.) Sterile

Distributed By:

AACE Pharmaceuticals, Inc., Fairfield, NJ 07004

www.aacepharma.com

Rev. 00

MURO 128® is a registered Trademark of Bausch and Lomb Pharmaceuticals, Inc. Tampa, Florida 33637.

cartoncarton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71406-123-35GM - Gram71406-123f6e1304b-2678-4f57-8484-662f665f601712020-04-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71406-12371406-123-35

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f2797fbd-ee5e-484e-e053-2995a90aba1aa0be67e3-742b-0bfd-e053-2995a90a976b2023-01-17WarningsExact identifier
spl set id: a0be67e3-742b-0bfd-e053-2995a90a976b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.