"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"...
(sertaconazole nitrate) Cream, 2%
ERTACZO (sertaconazole nitrate) cream, 2% is for topical application. It contains the azole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.
Sertaconazole nitrate is designated chemically as (±)-1-[2,4-dichloro-β-[(7-chlorobenzo-[b]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is C20H15Cl3N2OS • HNO3, and the structural formula is as follows:
Sertaconazole nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, sparingly soluble in alcohol and in methylene chloride. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base of ethylene glycol, glyceryl isostearate , glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, sorbic acid and purified water.
What are the possible side effects of sertaconazole topical (Ertaczo)?
Serious side effects are not expected to occur with the use of sertaconazole topical. Stop using sertaconazole topical and contact your doctor if you experience unusual or severe itching, redness, burning, blistering, swelling, oozing, or irritation of the skin.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...
What are the precautions when taking sertaconazole nitrate (Ertaczo)?
Before using sertaconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, ketoconazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 2/3/2014
This monograph has been modified to include the generic and brand name in many instances.
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