Lidocaine HCI

FDA Drug Profile — MEDI-FIRST Topical Analgesic, Lidotral 3.88% Roll on, Lidocaine HCI, TheraCare Roll-on Lidocaine Pain Relief Liquid - Lavender, FIRST SHIELD

Drug Details

Generic Name
Lidocaine HCI
Brand Names
MEDI-FIRST Topical Analgesic, Lidotral 3.88% Roll on, Lidocaine HCI, TheraCare Roll-on Lidocaine Pain Relief Liquid - Lavender, FIRST SHIELD, Electrum Numb Foam, HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent, Burn Gel, Pain Itch Relief, TheraCare Roll-on Lidocaine Pain Relief Liquid, GREEN GUARD Topical Pain Relief, HealthWise Roll-On Lidocaine Pain Relief Liquid
Application Number
M017
Sponsor
Ultra Distributors Inc
NDC Codes
12
Dosage Forms
SPRAY, GEL, CREAM, LIQUID, SOAP
Routes
TOPICAL
Active Ingredients
LIDOCAINE HYDROCHLORIDE, LIDOCAINE

Indications and Usage

INDICATIONS & USAGE Lidocaine Hydrochloride Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).

Warnings

WARNINGS 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 Jelly USP, 2% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption. When used for endotracheal tube lubrication, care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate the endotracheal stylettes. lf allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen. There have been rare reports in which this residue has caused the lumen to occlude. See also ADVERSE REACTIONS and DOSAGE & ADMINISTRATION .