NDC Code(s) : 0904-5314-35
Packager : Major Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sodium Chloride Hypertonicitysodium chloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-5314
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
(SODIUM CATION - UNII:LYR4M0NH37) 		SODIUM CHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-5314-351 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/01/2011

PRINCIPAL DISPLAY PANEL

Carton

NDC 0904-5314-35

Sodium Chloride Hypertonicity Ophthalmic Solution USP, 5%

(Sterile)

For temporary relief of Corneal Edema

1/2 fl oz (15mL)

MAJOR®