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Sodium Chloride Hypertonicity by Major Pharmaceuticals

Dosage form: solution
Ingredients: SODIUM CHLORIDE 50mg in 1mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-5314

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 Solution Drug Facts

Active ingredients

Sodium chloride 5%

Purpose

Hypertonicity agent

Uses

temporary relieve of corneal edema

Warnings

Do not use

  • except under the advice and supervision of a doctor
  • if solution changes color or becomes cloudy

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
 
instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.

Other information
  • store upright at 15° - 30°C (59° - 86°F)
  • keep tightly closed

 

Inactive ingredient

boric acid, hypromellose, propylene glycol, purified water, sodium borate. Sodium hydroxide ad/or hydrochloric acid may be added to adjust pH. PRESERVATIVE ADDED: methylparaben 0.023%, propylparaben 0.01%

Questions?

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

Package/Label Principal Display Panel

NDC 0904-5314-35

Sodium Chloride Hypertonicity Ophthalmic Solution USP, 5%

(Sterile)

For temporary relief of Corneal Edema

1/2 fl oz (15mL)

MAJOR®

SODIUM CHLORIDE HYPERTONICITY 
sodium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5314
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
HYPROMELLOSE 2208 (100 MPA.S) 
PROPYLENE GLYCOL 
WATER 
SODIUM BORATE 
METHYLPARABEN 
PROPYLPARABEN 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
Packaging
#Item CodePackage Description
1NDC:0904-5314-351 BOTTLE (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE
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

Revised: 12/2011
 
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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