FDA Label for One Touch Advanced Topical Anesthetic Bubble Gum
View Indications, Usage & Precautions
One Touch Advanced Topical Anesthetic Bubble Gum Product Label
The following document was submitted to the FDA by the labeler of this product Hager Worldwide, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
OneTouch
Advanced
Topical Anesthetic Gel Rx Only
| Active Ingredients: | |
| Benzocaine | 14.0% |
| Butamben | 2.0% |
| Tetracaine Hydrochloride | 2.0% |
Inactive Ingredient
Inactive Ingredients:
| Benzalkonium chloride | 0.5% |
| Cetyl Dimethyl Ethyl Ammonium Bromide | 0.005% |
| In bland, water-soluble base. |
Mechanism Of Action
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.
Indications & Usage
Indications
OneTouch Advanced Gel is a topical anesthetic indicated for the production
of anesthesia of all accessible mucous membrane except the eyes. OneTouch
Advanced Gel is indicated for use to control pain in the mouth.
Dosage & Administration
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 gently
depressing the pump. Dispensing a bead of gel in excess of 400 mg is contrain-
dicated. Spread thinly and evenly over the desired area using a 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 young
patients.
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 is
required. Anesthesia is produced within one minute with an approximate duration
of thirty minutes. Each 200 mg dose of OneTouch Advanced Gel contains 28 mg
of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCI.
Adverse Reactions
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 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-fect may also result from prolonged contact.
Precautions
Precaution: On rare occasions, methemoglobinemia has been reported in
connection with the use of benzocaine-containing products. Care should be
used not to exceed the maximum recommended dosage (see Dosage and
Administration). If a patient becomes cyanotic, treat appropriately to counteract
(such as with methylene blue, if medically indicated).
Pregnancy
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-known hazards. Routine precaution for the use of any topical anesthetic shouldbe observed when OneTouch Advanced Gel is used.
Contraindications
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, OneTouch
Advanced Gel should not be applied to large areas of denuded or inflamed
tissue. OneTouch Advanced Gel should not be administered to patients who are
hypersensitive 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, as
retention of the active gel ingredients under a denture or cotton roll could pos-
sibly cause an escharotic effect. Routine precaution for the use of any topical
anesthetic should be observed when using OneTouch Advanced Gel.
How Supplied
How-Supplied
OneTouch Advanced Gel, 32 g jar
| Cool Mint | NDC 62565-901-01 |
| Strawberry Ice | NDC 62565-902-01 |
| Bubble Gum | NDC 62565-903-01 |
| Cherry | NDC 62565-904-01 |
HAGER
WORLDWIDE
13322 Byrd Drive
Odessa, FL 33556 USA
Made in U.S.A. Rev. 6/09
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 approximately 1/4 to 1/2 inches long) by gently depressing the pump. Dispensing a bead in excess of 400 mg is contraindicated. Spread thinly and evenly over the desired area using a cotton swab. Active Ingredients: Benzocaine 14.0%, Butamben 2.0%, Tetracaine Hydrochloride 2.0% Inactive Ingredients: Benzalkonium Chloride 0.5%, Cetyl Dimethyl Ethyl Ammonium Bromide 0.005%, in a bland water-soluble base. | NDC 62565-903-01 OneTouch Advanced Topical Anesthetic Gel OneTouch Advanced is indicated for anesthesia of accessible mucous membrane. Bubble Gum Net Wt. 32 g Store in a cool dry place. | Manufactured for: HAGER WORLDWIDE Odessa, FL 33556 USA Item #6256590301 Made in U.S.A. Rev. 05/09 |
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