ONE TOUCH ADVANCED TOPICAL ANESTHETIC
45c23713-43da-45b7-bec4-85127e34ca7c
HUMAN PRESCRIPTION DRUG LABEL
Nov 23, 2011
HAGER WORLDWIDE, INC.
DUNS: 009277971
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (4)
Drug Labeling Information
INDICATIONS & USAGE SECTION
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 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 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.
PRECAUTIONS SECTION
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).