DESCRIPTION SECTION
| Active Ingredients: | |
| Benzocaine | 14.0% |
| Butamben | 2.0% |
| Tetracaine Hydrochloride | 2.0% |
INACTIVE INGREDIENT SECTION
| Benzalkonium chloride | 0.5% |
| Cetyl Dimethyl Ethyl Ammonium Bromide | 0.005% |
| In bland, water-soluble base. |
MECHANISM OF ACTION SECTION
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-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 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
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
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-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 a 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.
HOW SUPPLIED SECTION
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 |
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 62565-903-01OneTouchAdvancedTopical Anesthetic GelOneTouch Advancedis indicated for anesthesia ofaccessible mucous membrane.Bubble GumNet Wt. 32 gStore in a cool dry place. | Manufactured for:HAGERWORLDWIDEOdessa, FL 33556 USAItem #6256590301Made in U.S.A. Rev. 05/09 |