Mupirocin (Page 2 of 2)

Pediatrics

There were 91 pediatric patients aged 2 months to 15 years in the first study described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment (n=42) and 36% for vehicle placebo (n=49). In the second study described above, all patients were pediatric except two adults in the group receiving mupirocin ointment. The age range of the pediatric patients was 7 months to 13 years.

The clinical efficacy rate for mupirocin ointment (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

HOW SUPPLIED

Mupirocin Ointment USP, 2% is supplied
NDC 54868-4958-0 22 gram tube

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

*Bactroban® Nasal is a registered trademark of SmithKline Pharmaceuticals.

E. FOUGERA & CO.
A division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

I2352B
R9/07


Physicians Total Care, Inc.
Tulsa, OK 74146

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 22 G

FOUGERA ® Rx only

MUPIROCIN OINTMENT USP, 2%

For dermatologic use only.

Keep out of reach of
children.

NET WT 22 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 22 G
(click image for full-size original)
MUPIROCIN
mupirocin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4958(NDC:0168-0352)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUPIROCIN (MUPIROCIN) MUPIROCIN 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4958-0 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 22 g in 1 TUBE This package is contained within the CARTON (54868-4958-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065192 12/05/2003
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 04/2009 Physicians Total Care, Inc.

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