Is Xeroform a Medication? Regulatory Classification Explained
Is Xeroform a medication?
The Quick Answer
Xeroform is classified as a **medical device with antimicrobial properties**, not a systemic medication. Its active ingredient (3% bismuth tribromophenate) provides topical antimicrobial action without significant absorption—making it a 'medicated dressing' under FDA regulations but not a drug requiring prescription in most formulations.
Why We Ask This
Regulatory confusion leads patients to either overestimate Xeroform's infection-treating power (delaying antibiotics for true infections) or fear 'drug exposure' unnecessarily—both scenarios compromising optimal wound care decisions.
The Practical Science
FDA classifies impregnated dressings as Class II medical devices when antimicrobial action is secondary to wound management function. Bismuth tribromophenate's minimal systemic absorption (<0.01%) distinguishes it from true topical antibiotics requiring prescription.
In Clinical Practice
Xeroform prevents colonization in clean surgical wounds but wouldn't replace antibiotics for cellulitis—clinicians use it as adjunctive prophylaxis while systemic antibiotics address established infection, demonstrating appropriate risk-stratified application.
References & Context
Xeroform Petrolatum Dressing, Sterile, 2 x 2" box of 25""Xeroform Petrolatum Dressing is an antimicrobial wound dressing. INTENDED USES: These dressings are for when mild medication or deodorizing are required, such as postoperative applications, 1st and 2nd degree burns, and skin grafts. dressings, with the addition of 3% bismuth tribromophenate."