ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL COOL MINT- benzocaine, butamben, tetracaine hydrochloride gel

ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL by

Drug Labeling and Warnings

ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL by is a Prescription medication manufactured, distributed, or labeled by HAGER WORLDWIDE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: 62565-901-01; OneTouch; Advanced; Topical Anesthetic Gel; OneTouch Advanced; is indicated for anesthesia of; accessible mucous membrane.; Cool Mint; Net Wt. 32 g; Store in a cool dry place.

Manufactured for: HAGER; WORLDWIDE; Odessa, FL  33556 USA; Item #6256590101; Made in U.S.A.   Rev. 05/09

DESCRIPTION

OneTouch
Advanced

Topical Anesthetic Gel                                                                                                                                                                           Rx Only

• 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%

MECHANISM OF ACTION

Action
The onset of OneTouch Advanced-produced anesthesia is rapid (approximately
30 seconds) and the duration of anesthesia is typically 30-60 minutes, when
used as directed. This effect is due to the rapid onset, but short duration of
action of Benzocaine coupled with the slow onset, but extended duration of
Tetracaine 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 to
be absorbed by the mucous membrane and nerve sheath and then to diffuse
out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert
metabolites 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 any
aminobenzoate anesthetic. The most common adverse reaction caused by
local anesthetics is contact dermatitis characterized by erythema and pruritus
that may progress to vesiculation and oozing. This occurs most commonly in
patients following prolonged self-medication, which is contraindicated. If rash,
urticaria, edema, or other manifestations of allergy develop during use, the drug
should be discontinued. To minimize the possibility of a serious allergic reaction,
OneTouch Advanced Gel should not be applied for prolonged periods except
under 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 been
established 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 should
be 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

Manufactured for
HAGER
WORLDWIDE
13322 Byrd Drive
Odessa, FL 33556 USA

Made in U.S.A.        Rev. 6/09

INGREDIENTS AND APPEARANCE

ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL  COOL MINT
benzocaine, butamben, tetracaine hydrochloride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62565-901
Route of Administration	TOPICAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	28 mg  in .2 g
BUTAMBEN (UNII: EFW857872Q) (BUTAMBEN - UNII:EFW857872Q)	BUTAMBEN	4 mg  in .2 g
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE HYDROCHLORIDE	4 mg  in .2 g

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	1 mg  in .2 g

Product Characteristics
Color	green (GREEN)	Score
Shape		Size
Flavor	MINT (COOL MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62565-901-01	1 in 1 BOX
1		32 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2009

Labeler - HAGER WORLDWIDE, INC. (009277971)

Registrant - HAGER WORLDWIDE, INC. (009277971)

Establishment
Name	Address	ID/FEI	Business Operations
HAGER WORLDWIDE, INC.		009277971	manufacture