Sulfuric Acid / Sulfonated Phenolics

Pronunciation: SULL-fyoor-ick acid/SULL-fun-ated FEE-nahl-icks
Class: Mouth and throat product

Trade Names

Debacterol
- Liquid 30% sulfuric acid and 22% sulfonated phenolics

Pharmacology

Tissue denaturant and sterilizing agent.

Antiseptic agents with topical analgesic properties.

Indications and Usage

Topical treatment of ulcerating lesions of the oral cavity (eg, recurrent aphthous stomatitis [canker sores]); relief of pain and discomfort of oral mucosal ulcers; decrease risk of infection of ulcerated tissue.

Contraindications

Standard considerations.

Dosage and Administration

Before applying, dry the ulcerated area of oral mucosa using a sterile cotton-tipped applicator or similar method. Apply coated applicator directly to the dried ulcer bed, holding the applicator in contact with the ulcer for at least 5 sec, but not more than 10 sec, while using a rolling motion to thoroughly coat the entire ulcer bed, the ulcer rim, and surrounding halo of normal mucosa. Then, thoroughly rinse mouth with water and spit out the water. The stinging sensation and ulcer pain should subside almost immediately after rinsing. If the ulcer pain returns shortly after rinsing with water, some part of the ulcer may not have been covered during the application. A second application should be applied to the ulcer immediately during the same treatment session until it remains pain-free after rinsing. More than 1 treatment session is not recommended on an individual mucosal ulcer.

Storage/Stability

Store applicator at controlled room temperature (59° to 86°F).

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Other

Stinging and local irritation upon application.

Precautions

Pregnancy

Category C .

Children

Safety and efficacy not established in children under 12 yr.

Application

For external use only. Avoid prolonged use on normal tissue. Apply carefully because all tissue to which product is applied in sufficient volume will eventually necrotize and slough.

Ophthalmic exposure

Immediately remove any contact lenses and irrigate eyes for at least 15 min with lukewarm water and contact a health care provider.

Patient Information

• Advise patient that medication will be applied by a health care provider in a medical setting.
• Advise patient to inform health care provider if pain, burning, or stinging are felt after rinsing mouth.

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