SODIUM CHLORIDE - sodium chloride ointment 
Physicians Total Care, Inc.

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, Purified Water and White Petrolatum.

Principal Display Panel Text for Carton Label:

NDC 54868-4698-0

3.5 g

Sodium Chloride Ophthalmic Ointment USP, 5%

Hypertonicity

Eye Ointment

Comparable to MURO 128®

Sterile

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




image of package label

SODIUM CHLORIDE 
sodium chloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-4698(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:54868-4698-01 in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/30/2006
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-4698)

Revised: 9/2012
Document Id: a8c8707d-f588-4cd9-b5d6-93aca8fda7c4
Set id: f3af3709-3109-4d5c-8277-9bdfc3137e0f
Version: 1
Effective Time: 20120917
 
Physicians Total Care, Inc.