"Sage Products announced on July 29 that it is voluntarily recalling one lot of Comfort Shield Barrier Cream Cloths to the distributor and healthcare facility/user level because of product contamination with the bacterium Burkholderia"...
(mupirocin calcium) Cream
What is BACTROBAN cream?
It is not known if BACTROBAN cream is safe and effective in children under 3 months of age.
Who should not use BACTROBAN cream?
Do not use BACTROBAN cream if:
- you are allergic to mupirocin or any of the ingredients in BACTROBAN cream. See the end of this Patient Information leaflet for a complete list of the ingredients in BACTROBAN cream.
What should I tell my healthcare provider before using 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 hands before and after applying 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.
What are the possible side effects of BACTROBAN cream?
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
- swelling of your face, lips, mouth, or tongue
- a rash over your whole body
- trouble breathing or wheezing
- dizziness, fast heartbeat, or pounding in your chest
- 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 called clostridium 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:
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.
What are the ingredients in BACTROBAN cream?
Active Ingredient: mupirocin calcium
Inactive Ingredients: benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum
Last reviewed on RxList: 2/11/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Bactroban Cream Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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