SODIUM CHLORIDE- sodium chloride ointment 
Akorn

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.

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Drug Facts

Active ingredient

Sodium Chloride 5%

Purpose

Hypertonicity agent

Use

for temporary relief of corneal edema.

Warnings

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

Inactive ingredients

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

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 Text for Container Label

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
SODIUM CHLORIDE 
sodium chloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-622
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698) Sodium Chloride50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Mineral Oil (UNII: T5L8T28FGP)  
Lanolin (UNII: 7EV65EAW6H)  
Water (UNII: 059QF0KO0R)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-622-351 in 1 CARTON05/08/2006
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/08/2006
Labeler - Akorn (117696770)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(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
 
Akorn