FDA records indicate that there are no current recalls for this drug.
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Debacterol Canker Sore Pain Relief Recall
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Questions & Answers
Side Effects & Adverse Reactions
Keep out of reach of children. Do not use if allergic to a material that contains sulfur in any form. Because of its nature, prolonged use of Debacterol on normal tissue should be avoided. Debacterol will eventually necrotize and slough all tissue to which it is applied sufficient volume and should be applied carefully. Debacterol may be harmful with swallowed. If ingested do not induce vomiting. Immediately get medical help or contact a Poison Control Center. If eye exposure occurs, immediately remove any contact lenses and irrigate eyes for at least 15 minutes with lukewarm water and contact a physician.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Debacterol is indicated in the topical treatment of ulcerating lesions of the oral cavity such as Recurrent Aphthous Stomatitis (Canker Sores). Debacterol provides relief from the pain and discomfort of oral mucosal ulcers. Debacterol is not intended for the treatment of vesicular lesions, such as Cold Sores or Fever Blisters.
History
There is currently no drug history available for this drug.
Other Information
Debacterol is a dark brown, semi-viscous liquid. It contains sulfonated phenolics and sulfuric acid, which are tissue denaturants, in an aqueous solution.
Sources
Debacterol Canker Sore Pain Relief Manufacturers
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Epien Medical Inc
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