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Sodium Chloride Hypertonicity by Major Pharmaceuticals

Medically reviewed on December 18, 2017

Dosage form: ointment
Ingredients: SODIUM CHLORIDE 50mg in 1g
Labeler: Major Pharmaceuticals
NDC Code: 0904-5315

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.

Sodium Chloride Hypertonicity Ophthalmic Ointment Drug Facts

Active ingredients

Sodium chloride, 50 mg (5%)

Purpose

Hypertonicity agent

Uses

temporary relieve of corneal edema

Warnings

Do not use except under the advice and supervision of a doctor

When using this product  

it may cause temporary burning and irritation
do not touch tip of container to any surface to avoid contamination
replace cap after use

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions
 
pull down the lower lid of the affected eye

apply a small amount (1/4 inch) of ointment to the inside of eyelid

apply every 3 or 4 hours or as directed by a doctor

Other information
store at 15° - 30°C (59° - 86°F)
keep tightly closed
DO NOT FREEZE
See crimp of tube or carton for Lot Number and Expiration Date
Do not use if difficult to dispense or visible particles are seen in product

 

Inactive ingredient

lanolin, mineral oil, purified water, white petrolatum

Questions?

Serious side effects associated with use of this product may be reported to 1-800-323-0000

DO NOT ROLL, BEND, TWIST OR FOLD THE TUBE DURING USE AS THIS MAY CAUSE THE TUBE TO TEAR OR CRACK.

Package/Label Principal Display Panel

0904-5315-38

Sodium Chloride

Hypertonicity

Ophthalmic

Ointment, 5%

(Sterile)

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

MAJOR®

SODIUM CHLORIDE HYPERTONICITY 
sodium chloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5315
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN 
WATER 
PETROLATUM 
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:0904-5315-383.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/01/2011
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
Bausch & Lomb Incorporated807927397MANUFACTURE(0904-5315)

 
Major Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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