PerioRinse is manufactured in accordance with FDA regulations by an FDA registered manufacturer.
Mechanism of Action:
PerioRinse 0.1% mouth rinse contains a local anesthetic agent and is administered topically. PerioRinse 0.1% mouth rinse contains dyclonine HCl, which is chemically designated as 4'-butoxy-3- piperi-dinopropiophenone HCl. Each 5ml of PerioRinse 0.1% solution contains dyclonine HCl, 5 mg.
PerioRinse mouth rinse effects surface anesthesia when applied topically to mucous membranes. Effective anesthesia varies with different patients, but usually occurs from 2 to 10 minutes after application and persists for approximately 30-40 minutes. Periorinse mouth rinse is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, and esophagus). Health professionals have used PerioRinse topical solution to relieve sensitivity during routine teeth cleaning, to block the gag reflex, and to relieve the pain of oral ulcers of stomatitis. For adults a typical dose of 20ml vigourously swished for 2-3 minutes has given adequate anesthetic effect for up to 40 minutes prior to routine hygeine visits making patients comfortable and more likely to return for a 6 month follow-up. After swishing,the patient should expectorate (spit) the product. A bottle of 473ml PerioRinse should therefore be sufficent for approximately 24 patients. Practitioners have used PerioRinse to comfort patients during dental impressions. To help the gag reflex, patients have swished and also gargled PerioRinse to achieve best results.
When topical anesthetics are used in the mouth or throat, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. When PerioRinse 0.1% mouth rinse is used to relieve the pain of oral ulcers or stomatitis which interferes with eating, patients should be warned about the risk of biting trauma before they accept this treatment; caution should be exercised in selecting food and eating. Following other uses in the mouth and throat area, food and/or chewing gum should not be used while the area is anesthetized. Fertility Studies of dyclonine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted. Pregnancy, Teratogenic Effects, Pregnancy Category C: Animal reproduction studies have not been conducted with dyclonine. It is also not known whether dyclonine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. General consideration should be given to this fact before administering dyclonine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dyclonine is administered to a nursing woman.Dyclonine is contraindicated in patents known to be hypersensitive (allergic) to the local anesthetic or to other components of dyclonine HCl topical solutions. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age, weight and physical condition. Dyclonine should also be used with caution in patients with severe shock or heart block. PeriRinse mouth rinse should be used with caution in persons with known drug sensitivities.