SODIUM CHLORIDE HYPERTONICITY- sodium chloride solution
Major Pharmaceuticals

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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-5314
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-5314-35	1 in 1 CARTON	01/01/2011	02/25/2017
1		15 mL in 1 BOTTLE; 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	01/01/2011	02/25/2017

Labeler - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		807927397	MANUFACTURE(0904-5314)

Revised: 8/2018

Document Id: a8c34b42-1af3-4f5f-a3cc-48c2f9acf91b

Set id: 03f42d2a-cedc-4913-bced-3766cbf176e1

Version: 2

Effective Time: 20180806

Major Pharmaceuticals