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BACTROBAN- mupirocin calcium cream


  1. Patient Information
  2. Advise The Patient To Administer Bactroban Cream As Follows:
  3. Do Not Use Bactroban Cream If:
  4. Before Using Bactroban Cream, Tell Your Healthcare Provider About All Of Your Medical Conditions Including If You:
  5. How Should I Use Bactroban Cream?
  6. Bactroban Cream May Cause Serious Side Effects, Including:
  7. The Most Common Side Effects Of Bactroban Cream Include:
  8. How Should I Store Bactroban Cream?
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Revised: 5/2017document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Advise The Patient To Administer Bactroban Cream As Follows: 

Use BACTROBAN cream only as directed by the healthcare provider. It is for external use only. Avoid contact of BACTROBAN cream with the eyes. If BACTROBAN cream gets in the eyes, rinse thoroughly with water.
Do not use BACTROBAN cream in the nose.
Wash your hands before and after applying BACTROBAN cream.
Use a gauze pad or cotton swab to apply a small amount of BACTROBAN cream to the affected area. The treated area may be covered by gauze dressing if desired.
Report to the healthcare provider any signs of local adverse reactions. BACTROBAN cream should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs.
Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or tongue, or wheezing occur[

BACTROBAN cream is a prescription medicine used on the skin (topical use) to treat certain skin infections caused by bacteria calledStaphylococcus aureusandStreptococcus pyogenes.

It is not known if BACTROBAN cream is safe and effective in children under 3 months of age.

Do Not Use Bactroban Cream If: 

you are allergic to mupirocin or any of the ingredients in BACTROBAN cream.

Before Using Bactroban Cream, Tell Your Healthcare Provider About All Of Your Medical Conditions Including If You: 

are pregnant or plan to become pregnant. It is not known if BACTROBAN cream will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if BACTROBAN cream passes into your breast milk. You and your healthcare provider should decide if you can use BACTROBAN cream while breastfeeding.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not mix BACTROBAN cream with other lotions, creams, or ointments.

How Should I Use Bactroban Cream? 

BACTROBAN cream is for use on the skin (topical).Do not get BACTROBAN cream in your eyes, nose, mouth, or vagina (mucosal surfaces).
Use BACTROBAN cream exactly as your healthcare provider tells you to use it.
Apply a small amount of BACTROBAN cream, with a cotton swab or gauze pad, to the affected area 3 times each day. Apply BACTROBAN cream for 10 days.
It is important that you take the full course of BACTROBAN cream. Do not stop early because your symptoms may disappear before the infection is fully cleared.
Wash your handsbefore and afterapplying BACTROBAN cream.
After applying BACTROBAN cream, you may cover the treated area with a clean gauze pad, unless your healthcare provider has told you to leave it uncovered.
Talk to your healthcare provider if your skin does not improve after 3 to 5 days of treatment with BACTROBAN cream.
If you are breastfeeding and use BACTROBAN cream on your breast or nipple, wash the area well before breastfeeding your child.

Bactroban Cream May Cause Serious Side Effects, Including: 

severe allergic reactions.Stop using BACTROBAN cream and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:

hives trouble breathing or wheezing

swelling of your face, lips, mouth, or tongue dizziness, fast heartbeat, or pounding in your chest

a rash over your whole body

eye irritation. Do not get BACTROBAN cream in your eyes. If BACTROBAN cream gets in your eyes, rinse your eyes well with water.
irritation in the area BACTROBAN cream is used. A rash may occur after using BACTROBAN cream and can be severe. Stop using BACTROBAN cream and call your healthcare provider if you develop an irritation, severe itching, or a rash while using BACTROBAN cream.
a type of diarrhea calledclostridium difficile-associated diarrhea (CDAD).CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using BACTROBAN cream.

The Most Common Side Effects Of Bactroban Cream Include: 

headache
rash
nausea

These are not all the possible side effects of BACTROBAN cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Bactroban Cream? 

Store BACTROBAN cream at room temperature between 68 F to 77 F (20 C to 25 C).
Do not freeze BACTROBAN cream.
Keep BACTROBAN cream and all medicines out of the reach of children.

General information about the safe and effective use of BACTROBAN cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BACTROBAN cream for a condition for which it was not prescribed. Do not give BACTROBAN cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about BACTROBAN cream that is written for health professionals.

Active Ingredient: 

mupirocin calcium

Inactive Ingredients: 

benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum

BACTROBAN is a registered trademark of the GSK group of companies.

2017 the GSK group of companies. All rights reserved.

GlaxoSmithKline, Research Triangle Park, NC 27709

BBC:2PIL

For more information, call 1-888-825-5249.

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: May 2017

PRINCIPAL DISPLAY PANEL

NDC 0029-1527-22

BACTROBANCream

(mupirocin calcium cream, 2%)

15 grams(Net Wt.)

Rxonly

Do not use if seal on tube nozzle is broken

Made in England

2015 the GSK group of companies

10000000136830 Rev. 9/15
Bactroban Cream 15g carton
BACTROBAN
mupirocin calcium cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0029-1527
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MUPIROCIN CALCIUM(UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)MUPIROCIN20 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL(UNII: LKG8494WBH)
CETETH-20(UNII: I835H2IHHX)
CETYL ALCOHOL(UNII: 936JST6JCN)
MINERAL OIL(UNII: T5L8T28FGP)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
WATER(UNII: 059QF0KO0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
ColorWHITEScore
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0029-1527-221 in 1 CARTON01/23/1998
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0029-1527-251 in 1 CARTON01/23/1998
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA05074601/23/1998
Labeler -GlaxoSmithKline LLC (167380711)

Revised: 5/2017document Id: 

7fbf9ae2-228b-4e60-8867-d5cf9b318939Set id: 9257f9cd-abaf-4bb2-d9ac-4bc8f65ae558Version: 16Effective Time: 20170508GlaxoSmithKline LLC



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