REXALL ADVANCED RELIEF EYE DROPS- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride solution/ drops
K.C. Pharmaceuticals, Inc.

----------

Rexall Advanced Relief Eye Drops (MFR - EXPORT to CANADA)

Rexall Advanced Relief Eye Drops

Rexall Advanced Relief Eye Drops

REXALL ADVANCED RELIEF EYE DROPS
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55651-009
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	0.1 g in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	1 g in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55651-009-01	1 in 1 BOX	03/19/2023
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
Export only		03/19/2023

Labeler - K.C. Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc		174450460	manufacture(55651-009) , label(55651-009) , pack(55651-009)

Revised: 3/2023

Document Id: f7affc85-e663-7ddd-e053-6294a90a1583

Set id: f7affc6b-f430-af5e-e053-6394a90a5482

Version: 1

Effective Time: 20230324

K.C. Pharmaceuticals, Inc.