ADVERSE REACTIONS SECTION.
Adverse Reactions Hypersensitivity Reactions: Unpredictable adverse reactions (i.e. hypersensi--tivity, including anaphylaxis) are extremely rare. Localized allergic reactions may occur after prolonged or repeated use of anyaminobenzoate anesthetic. The most common adverse reaction caused bylocal anesthetics is contact dermatitis characterized by erythema and pruritusthat may progress to vesiculation and oozing. This occurs most commonly inpatients following prolonged self-medication, which is contraindicated. If rash,urticaria, edema, or other manifestations of allergy develop during use, the drugshould be discontinued. To minimize the possibility of serious allergic reaction,OneTouch Advanced Gel should not be applied for prolonged periods exceptunder continual supervision. Dehydration of the epithelium or an escharotic ef--fect may also result from prolonged contact.
Contraindications OneTouch Advanced Gel is not suitable and should never be used for injection.Do not use on the eyes. To avoid excessive systemic absorption, OneTouchAdvanced Gel should not be applied to large areas of denuded or inflamedtissue. OneTouch Advanced Gel should not be administered to patients who arehypersensitive to any of its ingredients or to patients known to have cholinest--erase deficiencies. Tolerance may vary with status of the patient. OneTouch Advanced Gel should not be used under dentures or cotton rolls, asretention of the active gel ingredients under denture or cotton roll could pos--sibly cause an escharotic effect. Routine precaution for the use of any topicalanesthetic should be observed when using OneTouch Advanced Gel.
OneTouchAdvanced Topical Anesthetic Gel Rx OnlyActive Ingredients:Benzocaine 14.0% Butamben 2.0% Tetracaine Hydrochloride 2.0%.
DOSAGE & ADMINISTRATION SECTION.
Dosage and Administration Only limited quantity is OneTouch Advanced Gel is required for anesthesia.Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gentlydepressing the pump. Dispensing bead of gel in excess of 400 mg is contrain--dicated. Spread thinly and evenly over the desired area using cotton swab. An appropriate pediatric dosage has not been established for OneTouch Ad--vanced Gel. Dosages should be reduced in the debilitated elderly, acutely ill, and very youngpatients. Tissue need not be dried prior to application of OneTouch Advanced Gel. One-Touch Advanced Gel should be applied directly to the site where pain control isrequired. Anesthesia is produced within one minute with an approximate durationof thirty minutes. Each 200 mg dose of OneTouch Advanced Gel contains 28 mgof benzocaine, mg of butamben and mg of tetracaine HCI.
HOW SUPPLIED SECTION.
How-Supplied OneTouch Advanced Gel, 32 jarCool Mint NDC 62565-901-01 Strawberry Ice NDC 62565-902-01 Bubble Gum NDC 62565-903-01 Cherry NDC 62565-904-01 Manufactured forHAGERWORLDWIDE13322 Byrd DriveOdessa, FL 33556 USAMade in U.S.A. Rev. 6/09.
INACTIVE INGREDIENT SECTION.
Inactive Ingredients:Benzalkonium chloride 0.5% Cetyl Dimethyl Ethyl Ammonium Bromide 0.005% In bland, water-soluble base.
INDICATIONS & USAGE SECTION.
Indications OneTouch Advanced Gel is topical anesthetic indicated for the productionof anesthesia of all accessible mucous membrane except the eyes. OneTouchAdvanced Gel is indicated for use to control pain in the mouth.
MECHANISM OF ACTION SECTION.
ActionThe onset of OneTouch Advanced-produced anesthesia is rapid (approximately30 seconds) and the duration of anesthesia is typically 30-60 minutes, whenused as directed. This effect is due to the rapid onset, but short duration ofaction of Benzocaine coupled with the slow onset, but extended duration ofTetracaine HCI and bridged by the intermediate action of Butamben.It is believed that all of these agents act by reversibly blocking nerve conduc--tion. Speed and duration of action is determined by the ability of the agent tobe absorbed by the mucous membrane and nerve sheath and then to diffuseout, and ultimately be metabolized (primarily by plasma cholinesterases) to inertmetabolites which are excreted in the urine.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Caution: Rx Only.Do not use in eyes. Keep out of reach of children. Directions: Read package insert.Press top of container to dispense desired amount.Dispense 200 mg of gel (a bead approximately1/4 to 1/2 inches long) by gently depressing thepump. Dispensing bead in excess of 400 mg iscontraindicated. Spread thinly and evenly over thedesired area using cotton swab. Active Ingredients: Benzocaine 14.0%,Butamben 2.0%, Tetracaine Hydrochloride 2.0% Inactive Ingredients: Benzalkonium Chloride0.5%, Cetyl Dimethyl Ethyl Ammonium Bromide0.005%, in bland water-soluble base. NDC 62565-903-01 OneTouchAdvanced Topical Anesthetic Gel OneTouch Advancedis indicated for anesthesia ofaccessible mucous membrane. Bubble Gum Net Wt. 32 Store in cool dry place. Manufactured for:HAGERWORLDWIDE Odessa, FL 33556 USA Item 6256590301 Made in U.S.A. Rev. 05/09 Image of principal jar label.
Precaution: On rare occasions, methemoglobinemia has been reported inconnection with the use of benzocaine-containing products. Care should beused not to exceed the maximum recommended dosage (see Dosage andAdministration). If patient becomes cyanotic, treat appropriately to counteract(such as with methylene blue, if medically indicated).
Use in Pregnancy: Safe use of One Touch Advanced Gel has not beenestablished with respect to possible adverse effects upon fetal development.Therefore, OneTouch Advanced Gel should not be used during early pregnancy,unless in the judgement of physician, the potential benefits outweigh the un--known hazards. Routine precaution for the use of any topical anesthetic shouldbe observed when OneTouch Advanced Gel is used.