Prescription Drug Information: Pre and Post Sx Pouch (Page 2 of 2)

CLINICAL STUDIES

The efficacy of topical mupirocin ointment USP, 2% in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either mupirocin ointment USP, 2% or vehicle placebo 3 times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for mupirocin ointment USP, 2% (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment USP, 2% and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment USP, 2%. In the second trial, subjects with impetigo were randomized to receive either mupirocin ointment USP, 2% 3 times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for mupirocin ointment USP, 2% (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable populations were 100% for both test groups. There were no side effects reported in the group receiving mupirocin ointment USP, 2%.

Pediatrics –

There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment USP, 2% (n=42) and 36% for vehicle placebo (n=49). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving mupirocin ointment USP, 2%. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment USP, 2% (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

HOW SUPPLIED

Mupirocin Ointment USP, 2% is available as follows:

22 g tube (NDC 45802- 112 -22)

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

*Bactroban Nasal® is a registered trademark of GlaxoSmithKline.

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard -Tenth Edition. CLSI document M07-A10 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.

2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.

3. Finlay JE, Miller LA, Poupard JA. Interpretive criteria for testing susceptibility of staphylococci to mupirocin. Antimicrob Agents Chemother 1997;41(5):1137-1139.

Made in Israel

Manufactured By Perrigo

Yeruham 80500, Israel

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 05-15

1N200 RC J6

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

Mupirocin Ointment USP, 2%

NET WT 22 g

Mupirocin Ointment
(click image for full-size original)

Dimethicone 5%

dimethicone
(click image for full-size original)

Chlorhexidine Gluconate 4%

chlor
(click image for full-size original)

Pre & Post Sx Pouch

Pre & Post Sx Pouch

Mupirocin 2%

Dimethicone 5%

Chlorhexidine Gluconate 4%

NDC 53225-5000-1

Lot #

Exp. Date

Terrain Pharmaceuticals

pouch
(click image for full-size original)
PRE AND POST SX POUCH
mupirocin 2%, dimethicone 5%, chlorhexidine gluconate 4% kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53225-5000
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53225-5000-1 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 22 g
Part 2 1 TUBE 118 mL
Part 3 1 BOTTLE, PLASTIC 118 mL
Part 1 of 3
MUPIROCIN
mupirocin ointment
Product Information
Item Code (Source) NDC:45802-112
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, UNSPECIFIED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-112-22 1 TUBE in 1 CARTON contains a TUBE
1 22 g in 1 TUBE This package is contained within the CARTON (45802-112-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065123 10/30/2009
Part 2 of 3
REMEDY DIMETHICONE MOISTURE BARRIER
dimethicone cream
Product Information
Item Code (Source) NDC:53329-151
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE
CITRIC ACID MONOHYDRATE
PROLINE
TAURINE
METHYLPARABEN
PROPYLPARABEN
VITAMIN A PALMITATE
ROSA CANINA FRUIT
STEARIC ACID
STEARYL ALCOHOL
EDETATE SODIUM (EDETIC ACID)
ALPHA-TOCOPHEROL
ALOE VERA LEAF
GLYCERYL MONOSTEARATE
GLYCINE
VANILLIN
GLYCERIN
DIMETHYL SULFONE
ACETYLCYSTEINE
POLYETHYLENE GLYCOL 400
POLYOXYL 100 STEARATE
PROPYLENE GLYCOL
PYRIDOXINE HYDROCHLORIDE
TROLAMINE
CORN OIL
NIACINAMIDE
WATER
ASCORBIC ACID
CETYL ALCOHOL
CHOLECALCIFEROL
DIAZOLIDINYL UREA
SUNFLOWER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53329-151-04 118 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/07/2007
Part 3 of 3
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate solution
Product Information
Item Code (Source) NDC:0116-1061
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLUCONOLACTONE
LAURAMINE OXIDE
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
WATER
COCO DIETHANOLAMIDE
ISOPROPYL ALCOHOL
TRIDECYL ALCOHOL
PEG-75 LANOLIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0116-1061-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 08/31/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/19/2018
Labeler — Terrain Pharmaceuticals (078358750)

Revised: 10/2021 Terrain Pharmaceuticals

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