Sulfonated phenolics; sulfuric acid solution is a chemical cautery agent used topically for the treatment of oral mucosal lesions, including aphthous ulcers (canker sores), ulcerative gingivitis, and oral lesions arising from systemic illness. In the treatment of aphthous ulcers, sulfonated phenolics; sulfuric acid solution has been shown to provide more rapid healing and pain relief when compared to triamcinolone acetonide paste or placebo. Cauterizing the oral lesion with sulfonated phenolics; sulfuric acid solution allows the healing process to begin immediately, and also provides almost immediate pain relief. Chemical cauterization may be a preferable treatment option for patients with oral mucosal lesions, as only one application is required compared to other topical treatments, which must be applied several times a day and provide transient pain relief. Although sulfonated phenolics; sulfuric acid solution penetrates and cauterizes mucosal lesions immediately, it is dilute enough to not cause damage to healthy oral mucosa. Sulfonated phenolics; sulfuric acid solution was originally approved for manufacture and sale in the U.S. in 1931.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Sulfonated phenolics; sulfuric acid solution is only intended for topical administration to the oral mucosa; it should not be injected, ingested, or applied to the eye or eyelids.
-Do not repeat treatment to the same area on successive days. A lesion should not be retreated unless it has undergone the complete healing process (several days) and has then reappeared.
No adverse reactions of clinical significance are expected. A brief stinging sensation may be immediately experienced upon application of sulfonated phenolics; sulfuric acid solution. This stinging sensation will subside almost immediately after the water rinse that follows application. If excess mucosal or skin irritation occurs during use or does not subside, use a dilute sodium bicarbonate solution to neutralize the reaction.
Sulfonated phenolics; sulfuric acid solution should not be used on individuals who are allergic to sulfonated phenolics.
Sulfonated phenolics; sulfuric acid solution is not intended for use on cold sores or lesions arising from herpes infection.
If sulfonated phenolics; sulfuric acid solution is used on normal tissue for prolonged periods of time it will eventual necrotize and slough all tissue to which it is applied. Sulfonated phenolics; sulfuric acid solution should be applied carefully, avoiding prolonged accidental exposure to healthy tissue. Sulfonated phenolics; sulfuric acid solution should not be applied to the same lesion on successive days. A lesion should not be retreated unless it has undergone the complete healing process (several days) and has then reappeared.
Sulfonated phenolics; sulfuric acid solution is classified as FDA pregnancy risk category C. Reproductive studies in humans and animals have not been conducted; it is not known if sulfonated phenolics; sulfuric acid solution causes fetal harm or affects reproductive capacity. Use with caution in pregnant women.
It is not known if sulfonated phenolics; sulfuric acid solution is excreted in breast milk following topical exposure, although the amount used in treatment would not be expected to appear in breast milk. Use with caution in breast-feeding women.
Safety and efficacy of sulfonated phenolics; sulfuric acid solution in neonates, infants or children < 12 years of age has not been established.
For the treatment of recurrent aphthous ulcer, acute necrotizing ulcerative gingivitis*, and oral lesions (stomatitis*) arising from systemic illness:
Topical dosage:
Adults, Adolescents, and Children > 12 years: After thoroughly drying the ulcerated oral mucosal area, dip a cotton tipped applicator into the sulfonated phenolics; sulfuric acid solution and apply it directly to the dried ulcerated area. Hold the applicator in contact with the ulcer, rolling it around to cover the entire ulcer and surrounding area, for at least 5-10 seconds. Have the patient thoroughly rinse their mouth with water and expectorate. If the patient still feels pain associated with the mucosal lesion it is an indication that the ulcer was not completely treated. The solution should be immediately reapplied to the area of the ulcer that was missed. After each application, have the patient thoroughly rinse their mouth with water and expectorate. Do not repeat treatment to the same area on successive days. A lesion should not be retreated unless it has undergone the complete healing process (several days) and has then reappeared.
Maximum Dosage Limits:
-Adults
No maximum dosage information is available.
-Elderly
No maximum dosage information is available.
-Adolescents
No maximum dosage information is available.
-Children
< 12 years: Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustment is needed.
Patients with Renal Impairment Dosing
No dosage adjustment is needed.
*non-FDA-approved indication
There are no drug interactions associated with Sulfonated Phenolics; Sulfuric Acid products.
Sulfonated phenolics; sulfuric acid solution penetrates and cauterizes ulcerated oral mucosa. Chemical cauterization with sulfonated phenolics; sulfuric acid solution essentially causes an acid burn, which denatures necrotic, infected tissue and, in turn, allows epithelial cells to begin immediate regeneration. In addition to allowing immediate regeneration of healthy epithelial cells, the denaturing effect on necrotic tissue causes the production of a type of tissue eschar at the point of contact, or a membrane of precipitated tissue debris. The formation of this eschar limits the penetration of sulfonated phenolics; sulfuric acid solution any further into healthy tissue and also provides a protective layer over the surface of the ulcer. Cauterization aids the immune system and enhances the healing process through sterilization of the ulcer site, accelerating the removal of necrotic debris, and creating a membranous layer of denatured tissue that promotes normal repair processes. The sulfuric acid component dehydrates and precipitates the necrotic tissue of the lesion by drawing up free water and oxidizing available organic polymers. The sulfonated phenolics component of the solution readily penetrates and disrupts the epithelial lining of the ulcerated oral mucosa. Because this process is immediate and complete during the application time (5-10 seconds), only one application of sulfonated phenolics; sulfuric acid solution is required for treatment of an oral lesion.
In addition, the sulfonated phenolics component penetrates the nerves, disrupting their ability to transmit pain signals. This renders the oral lesion pain free shortly after the solution is applied.
Pharmacokinetics:
Sulfonated phenolics; sulfuric acid solution is applied topically to the oral mucosa only. Sulfonated phenolics; sulfuric acid solution is minimally absorbed and therefore relatively free from systemic effects.
-Route-Specific Pharmacokinetics
Topical Route
Onset and duration of action are immediate, with effects obtained during the application time of approximately 5-10 seconds. While the duration of action and duration of effect are immediate, and after one application allow a decreased healing time of the oral lesion. Compared to normal, untreated aphthous ulcers, the healing time of aphthous ulcers treated with sulfonated phenolics; sulfuric acid solution is decreased from 14-16 days to 5-7 days. The onset of pain relief is immediate, following one application, and lasts throughout the duration of healing, compared to an untreated aphthous ulcer which exhibits pain almost throughout the entire duration of healing, typically reported to last 10-14 days.