WARNING: Life-threatening and fatal events in infants and young children
displayName: Boxed Warning section
FDA Article Code: 34066-1
Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
To decrease the risk of serious adverse events with use of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-, monohydrochloride and has the following structural formula:
The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34.
COMPOSITION OF SOLUTION
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Each mL contains 20 mg of lidocaine HCl. In addition each mL contains the following inactive ingredients: Carboxymethylcellulose sodium, methylparaben, natural orange flavor, propylparaben, purified water, and saccharin sodium. The pH is adjusted to 5.0 to 7.0 by means of hydrochloric acid and/or sodium hydroxide.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT.
THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy, or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups.
The solution should be stored at controlled room temperature 15° – 30°C (59° – 86°F).
SHAKE WELL BEFORE USE.
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Made in U.S.A.
Rev. 775:09 08/17
Package/Label Display Panel
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
LIDOCAINE HYDROCHLORIDE ORAL SOLUTION, USP (VISCOUS) 2%
NOTE: Squeeze bottle to dispense contents.
For Oral Use Only
Shake Well Before Using
Rx only 100 mL