MAJOR HYPERTONICITY- sodium chloride solution/ drops
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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Active ingredient Purpose

Sodium chloride 5%.............................Hypertonicity agent

Uses

- temporarily relief 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 to 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.

Other information

- store upright at 15° - 25°C (59° - 77°F)

- keep tightly closed

Inactive ingredients

boric acid, hydrochloric acid, hypromellose, methylparaben, propylene glycol, propylparaben, sodium borate, sodium hydroxide, purified water

Distributed by:

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

Made in Korea

MAJOR HYPERTONICITY
sodium chloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6490
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
HYDROCHLORIC ACID (UNII: QTT17582CB)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6490-35	1 in 1 CARTON	09/17/2015	11/30/2020
1		15 mL in 1 BOTTLE, DROPPER; 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	09/17/2015	11/30/2020

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020

Document Id: 0ea8ad9c-c7f0-4faf-a775-06654ad6dcb7

Set id: 488ac504-f707-4468-8ca9-3afd0b079ee3

Version: 4

Effective Time: 20200103

Major Pharmaceuticals