NDC Code(s) : 0904-2992-35
Packager : Major Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OptiClearTetrahydrozoline HCl SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-2992
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRAHYDROZOLINE HYDROCHLORIDE(UNII: 0YZT43HS7D)
(TETRAHYDROZOLINE - UNII:S9U025Y077) 		TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID(UNII: R57ZHV85D4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM BORATE(UNII: 91MBZ8H3QO)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-2992-3515 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 10/07/2011

PRINCIPAL DISPLAY PANEL

Carton

NDC 0904-2992-35

MAJOR®

STERILE

OPTI-CLEAR

Tetrahydrozoline Hydrochloride Ophthalmic Solution, USP

Redness Reliever Eye Drops

For minor eye irritations

1/2 fl oz (15 mL)

Compared to active ingredient of Visine®* Original