OPTION PLUS ADVANCED RELIEF EYE DROPS- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride solution/ d

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68), POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ), POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E), TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)

Tilgjengelig fra:

K.C. Pharmaceuticals, Inc.

Administreringsrute:

OPHTHALMIC

Resept typen:

OTC DRUG

Autorisasjon status:

Export only

Preparatomtale

OPTION PLUS ADVANCED RELIEF EYE DROPS- DEXTRAN 70, POLYETHYLENE GLYCOL
400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION/ DROPS
K.C. PHARMACEUTICALS, INC.
----------
OPTION PLUS ADVANCED RELIEF EYE DROPS (MFR - EXPORT TO CANADA)
OPTION PLUS ADVANCED RELIEF EYE DROPS
OPTION PLUS ADVANCED RELIEF EYE DROPS
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline
hydrochloride solution/ drops
K.C. Pharmaceuticals, Inc.
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55651-007
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
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)
TETRAHYDROZ OLINE
HYDROCHLORIDE
0.05 g
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:55651-
007-01
1 in 1 BOX
03/19/2023
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
Export only
03/19/2023
LABELER -
K.C. Pharmaceuticals, Inc. (174450460)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
KC Pharmaceuticals, Inc
174450460
manufacture(55651-007) , label(55651-007) , pack(55651-007)
Revised: 3/2023