MAJOR HYPERTONICITY- sodium chloride solution/ drops

Major Hypertonicity by

Drug Labeling and Warnings

Major Hypertonicity by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                   Purpose

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

PURPOSE

Uses

- temporarily relief of corneal edema

WARNINGS

Warnings

Do not use

- except under the advice and supervision of a doctor

- if solution changes color or becomes cloudy

WHEN USING

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

ASK DOCTOR

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

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

STORAGE AND HANDLING

Other information

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

- keep tightly closed

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed by:

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAJOR HYPERTONICITY 
sodium chloride solution/ drops

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/17/2015	11/30/2020

Labeler - Major Pharmaceuticals (191427277)