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ONE TOUCH ADVANCED TOPICAL ANESTHETIC

Approved
Approval ID

45c23713-43da-45b7-bec4-85127e34ca7c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 23, 2011

Manufacturers
FDA

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
NDC Product Code62565-903
Product Classification
G
Generic Name
BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationTOPICAL, DENTAL
Effective DateNovember 23, 2011
FDA Product Classification

INGREDIENTS (4)

BENZOCAINEActive
Quantity: 28 mg in .2 g
Code: U3RSY48JW5
Classification: ACTIB
BUTAMBENActive
Quantity: 4 mg in .2 g
Code: EFW857872Q
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 1 mg in .2 g
Code: F5UM2KM3W7
Classification: IACT
TETRACAINE HYDROCHLORIDEActive
Quantity: 4 mg in .2 g
Code: 5NF5D4OPCI
Classification: ACTIB

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/23/2011

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

LOINC: 34068-7Updated: 11/23/2011

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

LOINC: 42232-9Updated: 11/23/2011

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).

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ONE TOUCH ADVANCED TOPICAL ANESTHETIC - FDA Drug Approval Details