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Questions & Answers
Side Effects & Adverse Reactions
IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS MUST BE IMMEDIATELY AVAILABLE WHEN LOCAL ANESTHETIC AGENTS, SUCH AS LIDOCAINE, ARE ADMINISTERED TO MUCOUS MEMBRANES.
The DentiPatch® system should be used with extreme caution if there is sepsis or extremely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
The DentiPatch® system is indicated for the production of mild topical anesthesia of the accessible mucous membranes of the mouth prior to superficial dental procedures. It may also reduce the pain associated with injections of local anesthetic into the gingiva.
There is currently no drug history available for this drug.
The DentiPatch® system contains a local anesthetic agent to be applied topically to the oral cavity. See INDICATIONS for specific uses.
Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula:
The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34.
Each 2 cm2 patch contains lidocaine base as the active ingredient in the amount of 46.1 mg. Non-active ingredients include: karaya gum, glycerin, dipropylene glycol, lecithin, propylene glycol, aspartame, spearmint flavor, polyester film laminate and polyester-rayon fabric.
Each unit is sealed in a paper polyethylene-foil pouch.