Label at a glance#

ProductONE TOUCH ADVANCED TOPICAL ANESTHETIC CHERRY

Active ingredientBENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE

Label structure11 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

OneTouch
Advanced

Topical Anesthetic Gel Rx Only

Active Ingredients:
Benzocaine	14.0%
Butamben	2.0%
Tetracaine Hydrochloride	2.0%

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Benzalkonium chloride	0.5%
Cetyl Dimethyl Ethyl Ammonium Bromide	0.005%
In bland, water-soluble base.

MECHANISM OF ACTION SECTION

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 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.

ADVERSE REACTIONS SECTION

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 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).

PREGNANCY SECTION

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 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, 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 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

Manufactured for
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 62565-904-01
OneTouch
Advanced

Topical Anesthetic Gel
OneTouch Advanced
is indicated for anesthesia of
accessible mucous membrane.

Cherry
Net Wt. 32 g

Store in a cool dry place.

Manufactured for:
HAGER
WORLDWIDE
Odessa, FL 33556 USA

Item #6256590401

Made in U.S.A. Rev. 05/09

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62565-904-01	2025-02-04	C162847	48780-1	9d75b9d0-6b08-f424-e053-dadaa90a57ce	e3f6da72-5a7e-49c1-973d-8f19088beabb
62565-904-01	2020-01-31	C162847	48780-1	9d75b9d0-6b08-f424-e053-dadaa90a57ce	e3f6da72-5a7e-49c1-973d-8f19088beabb

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
BUTAMBEN	ACTIVE INGREDIENT	EFW857872Q	1
TETRACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	5NF5D4OPCI	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
BUTAMBEN	ACTIVE MOIETY	EFW857872Q	1
TETRACAINE	ACTIVE MOIETY	0619F35CGV	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

ONE TOUCH ADVANCED TOPICAL ANESTHETIC CHERRY
BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
BENZOCAINE
BUTAMBEN
TETRACAINE HYDROCHLORIDE
TETRACAINE
BENZALKONIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62565-904	62565-904-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
BUTAMBEN	EFW857872Q	ACTIB
TETRACAINE HYDROCHLORIDE	5NF5D4OPCI	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRALESIONAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / TOPICAL	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	OINTMENT / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / NASAL	40.46 mg/100ml		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LIQUID / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / AURICULAR (OTIC)	0 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2d5796f9-c446-4ac7-e063-6294a90a67ec			e3f6da72-5a7e-49c1-973d-8f19088beabb	2025-02-04	Adverse reactions	Exact identifier spl set id: e3f6da72-5a7e-49c1-973d-8f19088beabb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.