Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
EPIEN Medical Inc
128678765
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEBACTEROL Canker Sore Pain Relief
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
DESCRIPTION SECTION
Debacterol is a dark brown, semi-viscous liquid. It contains sulfonated phenolics and sulfuric acid, which are tissue denaturants, in an aqueous solution.
INDICATIONS & USAGE SECTION
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.
PRECAUTIONS SECTION
Debacterol is for use in the oral cavity only. Avoid eye contact. Saftey and effectiveness in pregnant women and children under the age of 12 has not been established.
SPL UNCLASSIFIED SECTION
DEBACTEROL Canker Sore Pain Relief