ONE TOUCH ADVANCED TOPICAL ANESTHETIC Dailymed
Go PRO for all pill images
Description Section
OneTouchAdvanced Topical Anesthetic Gel                                                                                                                     Rx Only
Active Ingredients: Benzocaine 14.0% Butamben 2.0% Tetracaine Hydrochloride 2.0%
Inactive Ingredient Section
Inactive Ingredients:
Benzalkonium chloride 0.5% Cetyl Dimethyl Ethyl Ammonium Bromide 0.005% In bland, water-soluble base.
Mechanism Of Action Section
Action The 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-Âtion. 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.
Indications & Usage Section
Indications OneTouch Advanced Gel is a 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.
Dosage & Administration Section
Dosage and Administration Only a 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 a bead of gel in excess of 400 mg is contrain-Âdicated. Spread thinly and evenly over the desired area using a cotton swab. An appropriate pediatric dosage has not been established for OneTouch Ad-Âvanced 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, 4 mg of butamben and 4 mg of tetracaine HCI.
Adverse Reactions Section
Adverse Reactions Hypersensitivity Reactions: Unpredictable adverse reactions (i.e. hypersensi-Âtivity, 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 a serious allergic reaction,OneTouch Advanced Gel should not be applied for prolonged periods exceptunder continual supervision. Dehydration of the epithelium or an escharotic ef-Âfect may also result from prolonged contact.
Precautions Section
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 a patient becomes cyanotic, treat appropriately to counteract(such as with methylene blue, if medically indicated).
Pregnancy Section
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 a physician, the potential benefits outweigh the un-Âknown hazards. Routine precaution for the use of any topical anesthetic shouldbe observed when OneTouch Advanced Gel is used.
Contraindications Section
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-Âerase 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 a denture or cotton roll could pos-Âsibly cause an escharotic effect. Routine precaution for the use of any topicalanesthetic should be observed when using OneTouch Advanced Gel.
How Supplied Section
How-Supplied OneTouch Advanced Gel, 32 g jar
Manufactured for HAGERWORLDWIDE 13322 Byrd DriveOdessa, FL 33556 USA Made in U.S.A.       Rev. 6/09
Cool Mint NDC 62565-901-01 Strawberry Ice NDC 62565-902-01 Bubble Gum NDC 62565-903-01 Cherry NDC 62565-904-01
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 a bead in excess of 400 mg iscontraindicated. Spread thinly and evenly over thedesired area using a 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 a bland water-soluble base. NDC 62565-902-01 OneTouchAdvanced Topical Anesthetic Gel OneTouch Advancedis indicated for anesthesia ofaccessible mucous membrane. Strawberry Ice Net Wt. 32 g Store in a cool dry place. Manufactured for: HAGER WORLDWIDE Odessa, FL 33556 USA Item #6256590201 Made in U.S.A.  Rev. 05/09 
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
