BACTROBAN mupirocin calcium ointment

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)

Prieinama:

Glaxo Opoerations UK Ltd

INN (Tarptautinis Pavadinimas):

MUPIROCIN CALCIUM

Sudėtis:

MUPIROCIN 20 mg in 1 g

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Prekės savybės

BACTROBAN- MUPIROCIN CALCIUM OINTMENT
GLAXO OPOERATIONS UK LTD
----------
BACTROBAN NASAL
(MUPIROCIN CALCIUM OINTMENT, 2%)
FOR INTRANASAL USE ONLY
PRINCIPAL DISPLAY PANEL
NDC 0029-1526-11
_BACTROBAN (MUPIROCIN CALCIUM)_
_NASAL OINTMENT, 2%_
10 x 1.0 gram Single-Use Tubes
THIS SHRINK-WRAPPED UNIT REPRESENTS ONE 5-DAY COURSE OF THERAPY.
Store at 20
- 25 C (68 – 77 F); excursions permitted 15 - 30 C (59 – 86 F). Do
not refrigerate.
DO NOT USE IF SEAL ON TUBE NOZZLE IS BROKEN.
USUAL DOSAGE: For intranasal use only. Apply one-half the contents of
a tube in one nostril. Apply other
half of tube contents in other nostril. See accompanying prescribing
information.
GlaxoSmithKline
Research Triangle Park, NC 27709
BACTROBAN
mupirocin calcium ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 3379 -0 0 2
ROUTE OF ADMINISTRATION
TOPICAL
®
o
o
o
o
o
o
o
o
10000000136205 Rev. 8/15
Glaxo Opoerations UK Ltd
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MUPIRO CIN CALCIUM (UNII: RG38 I2P540 ) (MUPIROCIN - UNII:D0 GX8 6
3OA5)
MUPIROCIN
20 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PARAFFIN (UNII: I9 O0 E3H2ZE)
PRODUCT CHARACTERISTICS
COLOR
WHITE (white to o ff-white)
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 3379 -0 0 2-0 2
10 in 1 PACKAGE
0 4/10 /19 9 6
1
NDC:6 3379 -0 0 2-0 1
1 in 1 CARTON
1
1 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH
CITA TIO N
MARKE TING START
DATE
MARKE TING END
DATE
Appro ved Drug Pro duct Manufactured Under
Co ntra c t
NDA0 50 70 3
0 4/10 /19 9 6
LABELER -
Glaxo Opoerations UK Ltd (424738227)
REGISTRANT -
GlaxoSmithKline LLC (167380711)
Revised: 11/2017