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NDC 17478-0622-35 Sodium Chloride 50 mg/g Details

Sodium Chloride 50 mg/g

Sodium Chloride is a OPHTHALMIC OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. The primary component is SODIUM CHLORIDE.

Product Information

NDC	17478-0622
Product ID	17478-622_cd581639-c1fb-4d6a-aefe-4723251dec9e
Associated GPIs	86804030104205
GCN Sequence Number	007737
GCN Sequence Number Description	sodium chloride OINT. (G) 5 % OPHTHALMIC
HIC3	Q6A
HIC3 Description	OPHTHALMIC PREPARATIONS, MISCELLANEOUS
GCN	31880
HICL Sequence Number	003389
HICL Sequence Number Description	SODIUM CHLORIDE
Brand/Generic	Generic
Proprietary Name	Sodium Chloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	OPHTHALMIC
Active Ingredient Strength	50
Active Ingredient Units	mg/g
Substance Name	SODIUM CHLORIDE
Labeler Name	Akorn
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17478-0622-35 (17478062235)

Pricing Information
NDC Package Code	17478-622-35
Billing NDC	17478062235
Package	1 TUBE in 1 CARTON (17478-622-35) / 3.5 g in 1 TUBE
Marketing Start Date	2006-05-08
NDC Exclude Flag	N
Price Per Unit	2.84338
Pricing Unit	GM
Effective Date	2022-09-21
NDC Description	SODIUM CHLORIDE 5% EYE OINT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL e00f4d11-0999-452a-87bb-4d477db294a6 Details

SPL UNCLASSIFIED SECTION

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 reach of children.

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

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 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 Control Number and Expiration Date.
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Mineral Oil, Modified Lanolin, Water for Injection and White Petrolatum.

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-622-35

Sodium Chloride Ophthalmic

Ointment USP, 5%

Hypertonicity Eye Ointment Sterile

FOR OPHTHALMIC USE ONLY. Net Wt. 3.5 g (1/8 oz.)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-622-35

3.5 g

Sodium

Chloride

Ophthalmic

Ointment

USP, 5%

Hypertonicity

Eye Ointment

Comparable to MURO 128®

Sterile

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

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE

sodium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-622
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698)	Sodium Chloride	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Mineral Oil (UNII: T5L8T28FGP)
Lanolin (UNII: 7EV65EAW6H)
Water (UNII: 059QF0KO0R)
Petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17478-622-35	1 in 1 CARTON	05/08/2006
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	05/08/2006

Labeler - Akorn (117696770)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(17478-622) , ANALYSIS(17478-622) , STERILIZE(17478-622) , PACK(17478-622) , LABEL(17478-622)

Revised: 2/2022

Document Id: cd581639-c1fb-4d6a-aefe-4723251dec9e

Set id: e00f4d11-0999-452a-87bb-4d477db294a6

Version: 6

Effective Time: 20220207

Search by Drug Name or NDC

NDC 17478-0622-35 Sodium Chloride 50 mg/g Details

Sodium Chloride 50 mg/g

Product Information

Package

Package Images

NDC 17478-0622-35 (17478062235)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e00f4d11-0999-452a-87bb-4d477db294a6 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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