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Sulfonated Phenolics and Sulfuric Acid

Medically reviewed by Drugs.com. Last updated on Jan 29, 2024.

Pronunciation

(SUL fo NATE ed fe NOL iks & SUL fyoor ik AS id)

Index Terms

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, topical [for oral mucosa]:

Debacterol®: Sulfonated phenolics 50% and sulfuric acid 30% (1.5 mL) [for professional use only]

Swab, topical [for oral mucosa]:

Debacterol®: Sulfonated phenolics 50% and sulfuric acid 30% (12s) (0.2 mL) [for professional use only]

Brand Names: U.S.

Pharmacologic Category

Pharmacology

Semiviscous, chemical cautery agent which provides controlled, focal debridement and sterilization of necrotic tissues; relieving pain, sealing damaged tissue, and providing local antiseptic action

Use: Labeled Indications

Oral ulcers: Treatment of ulcerating oral lesions such as recurrent aphthous stomatitis (canker sores)

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Oral ulcers: Topical: Apply 1 coated applicator swab to ulcer for 5 to 10 seconds. Note: Not recommended to apply more than 1 treatment to each ulcer; however, if ulcer pain returns shortly after rinsing with water, 1 repeat application may be used.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Oral ulcers: Topical: Children ≥12 years and Adolescents: Refer to adult dosing.

Administration

For external use only; avoid contact with eyes. Prior to application/treatment, the ulcerated mucosal area should be thoroughly dried with a cotton-tipped applicator or similar method. After drying, apply solution coated applicator swab directly to the ulcerated area (most patients experience a brief stinging sensation immediately) and hold the applicator in contact with the ulcer for at least 5 to 10 seconds. Thoroughly rinse out the mouth with water and spit out the rinse water. The stinging sensation and ulcer pain will subside almost immediately after the rinse.

Storage

Store at room temperature of 15°C to 30°C (59°F to 86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

Local: Local irritation (upon administration)

Warnings/Precautions

Concerns related to adverse effects:

• Irritation: If excess irritation occurs, rinse with a sodium bicarbonate (baking soda) solution (1/2 teaspoonful mixed in 120 mL [4 oz] water); if irritation persists, contact health care provider.

Dosage form specific issues:

• Sulfur: Do not use if allergic to sulfur in any form.

Other warnings/precautions:

• Accidental ingestion: If ingested, do not induce vomiting; rinse out mouth and immediately dilute liquids (no more than 8 ounces in adults and 4 ounces in children) and get medical help or contact a Poison Control Center.

• Appropriate use: For topical use only. Debacterol® is not intended for the treatment of cold sores and fever blisters. Prolonged use of Debacterol on normal tissue should be avoided.

• Eye exposure: Avoid contact with eyes. If eye exposure occurs, immediately remove contact lenses, irrigate eyes for at least 15 minutes with lukewarm water, and contact a physician.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.