NDC Code(s) : 66613-8159-1
Packager : Rohto Pharmaceutical Co. Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rohto Naphazoline hydrochloride, Polysorbate 80 LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66613-8159
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPHAZOLINE HYDROCHLORIDE(UNII: MZ1131787D)
(NAPHAZOLINE - UNII:H231GF11BV) 		NAPHAZOLINE HYDROCHLORIDE.3 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)
(POLYSORBATE 80 - UNII:6OZP39ZG8H) 		POLYSORBATE 802 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)1 mg in 1 mL
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
BORIC ACID(UNII: R57ZHV85D4)
CHLOROBUTANOL(UNII: HM4YQM8WRC)
EDETATE DISODIUM(UNII: 7FLD91C86K)
MENTHOL(UNII: L7T10EIP3A)
POTASSIUM ASPARTATE(UNII: OC4598NZEQ)
WATER(UNII: 059QF0KO0R)
SODIUM BORATE(UNII: 91MBZ8H3QO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66613-8159-11 in 1 CARTON 05/05/2014
113 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 05/05/2014

PRINCIPAL DISPLAY PANEL

Rohto Cool Max