OTC Medication Information: Sodium Chloride

SODIUM CHLORIDE- sodium chloride ointment
CVS Pharmacy

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.

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 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

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 the reach of children.

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

Questions or comments? 1-800-932-5676

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 controlled room temperature 20° to 25°C (68° to 77°F).
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.
  • See crimp for Control Number and Expiration Date.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Mineral Oil, Modified Lanolin, Purified Water and White Petrolatum.

Principal Display Panel Text for Container Label:

CVS Health Logo NDC 59779-303-01

Sodium Chloride USP, 5%

HYPERTONICITY OPHTHALMIC OINTMENT

NET WT 0.125 OZ (3.5 g) STERILE

Principal Display Panel Text for Container Label
(click image for full-size original)

Principal Display Panel Text for Carton Label:

CVS Health Logo Compare to the active

ingredient in Muro® 128*

Sodium Chloride, NDC 59779-303-01

USP, 5%

HYPERTONICITY OPHTHALMIC OINTMENT

Temporary relief of corneal edema

NET WT 0.125 OZ (3.5 g) STERILE

Principal Display Panel Text for Carton Label
(click image for full-size original)
SODIUM CHLORIDE
sodium chloride ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-303
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Chloride (Sodium Cation) Sodium Chloride 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Mineral Oil
Lanolin
Water
Petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-303-01 1 TUBE in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (59779-303-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 02/21/2013
Labeler — CVS Pharmacy (062312574)
Registrant — Akorn Operating Company LLC (117693100)
Establishment
Name Address ID/FEI Operations
Akorn, Inc 117696840 MANUFACTURE (59779-303), ANALYSIS (59779-303), STERILIZE (59779-303), PACK (59779-303), LABEL (59779-303)

Revised: 10/2020 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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