FDA records indicate that there are no current recalls for this drug.
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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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Dentipatch Manufacturers
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Noven Parmaceuticals, Inc.
Dentipatch | Noven Parmaceuticals, Inc.
When the DentiPatch® system is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.
Isolate the procedure area with cotton rolls and use suction as appropriate. Dry the tissue with air or gauze. Remove the DentiPatch® system from its packaging and peel off the clear protective liner. Immediately apply the DentiPatch® system using firm pressure. Allow the patch to remain in place until the desired anesthetic effect is produced but not for longer than 15 minutes. Experience in children is inadequate to recommend a pediatric dose at this time.
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