Cetacaine Topical Anesthetic

Benzocaine, Butamben, And Tetracaine Hydrochloride

Cetylite Industries, Inc.
Human Prescription Drug
NDC 10223-0217

Cetacaine Topical Anesthetic also known as Benzocaine, Butamben, And Tetracaine Hydrochloride is a human prescription drug labeled by 'Cetylite Industries, Inc.'. National Drug Code (NDC) number for Cetacaine Topical Anesthetic is 10223-0217. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Cetacaine Topical Anesthetic drug includes Benzocaine - .028 g/.2g Butamben - .004 g/.2g Tetracaine Hydrochloride - .004 g/.2g . The currest status of Cetacaine Topical Anesthetic drug is Active.

Drug Information:

Drug NDC:	10223-0217
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Cetacaine Topical Anesthetic
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Benzocaine, Butamben, And Tetracaine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Cetylite Industries, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	BENZOCAINE - .028 g/.2g BUTAMBEN - .004 g/.2g TETRACAINE HYDROCHLORIDE - .004 g/.2g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	01 Jan, 1960
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	11 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Cetylite Industries, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	209970 308645
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000185508 N0000175629 N0000184306 M0000728
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	EFW857872Q 5NF5D4OPCI U3RSY48JW5
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Standardized Chemical Allergen [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Ester Local Anesthetic [EPC] Esters [CS] Increased Histamine Release [PE] Local Anesthesia [PE] Standardized Chemical Allergen [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
10223-0217-3	1 JAR in 1 BOX (10223-0217-3) / 32 g in 1 JAR	01 Jan, 1960	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Cetacaine Topical Anesthetic

Benzocaine, Butamben, And Tetracaine Hydrochloride

Gel
Cetylite Industries, Inc.
NDC: 10223-0221

Cetacaine Anesthetic

Benzocaine, Butamben, And Tetracaine Hydrochloride

Aerosol, Spray
Cetylite Industries, Inc.
NDC: 10223-0201

Cetacaine Anesthetic

Benzocaine, Butamben, And Tetracaine Hydrochloride

Solution
Cetylite Industries, Inc.
NDC: 10223-0202

Cetacaine Topical Anesthetic

Benzocaine, Butamben, And Tetracaine Hydrochloride

Gel
Cetylite Industries, Inc.
NDC: 10223-0217

Product Elements:

Cetacaine topical anesthetic benzocaine, butamben, and tetracaine hydrochloride benzocaine benzocaine butamben butamben tetracaine hydrochloride tetracaine polyethylene glycol, unspecified saccharin benzalkonium chloride mecetronium bromide water cetacaine topical anesthetic benzocaine, butamben, and tetracaine hydrochloride benzocaine benzocaine butamben butamben tetracaine hydrochloride tetracaine polyethylene glycol, unspecified saccharin benzalkonium chloride mecetronium bromide water

Drug Interactions:

Drug interactions patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: class examples nitrates/nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid antimalarials chloroquine, primaquine anticonvulsants phenytoin, sodium valproate, phenobarbital other drugs acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine

Indications and Usage:

Indications cetacaine topical anesthetic gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. cetacaine topical anesthetic gel is indicated for use to control pain and for use for surgical or endoscopic procedures, or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. it may also be used for vaginal or rectal procedures where feasible.

Warnings:

Warnings and precautions methemoglobinemia cases of methemoglobinemia have been reported in association with local anesthetic use. although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. if local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, includ Read more...

ing seizures, coma, arrhythmias, and death. discontinue cetacaine and any other oxidizing agents. depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. more severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Dosage and Administration:

Dosage and administration only a limited quantity of cetacaine topical anesthetic 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 contraindicated. spread thinly and evenly over the desired area using a cotton swab. in the unlikely event that a cetacaine gel pump jar won't dispense, attempt the following: using a gloved hand, depress the pump fully using the thumb and middle finger. while depressed, cover the center orifice with the index finger. with the orifice still covered, slowly allow the pump to return to its original starting position. repeat until cetacaine gel is dispensed (usually about 3-4 repeated attempts). an appropriate pediatric dosage has not been established for cetacaine topical anesthetic gel. dosages should be reduced in the debilitated elderly, acutely ill, and very young patients. do not use cetacaine gel to treat infants or children Read more...

younger than 2 years. tissue need not be dried prior to application of cetacaine topical anesthetic gel. cetacaine topical anesthetic gel should be applied directly to the site where pain control is required. anesthesia is produced in approximately 30 seconds with an approximate duration of thirty to sixty minutes. each 200 mg dose of cetacaine topical anesthetic gel contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine hcl.

Contraindications:

Contraindications do not use cetacaine gel to treat infants or children younger than 2 years. cetacaine is not suitable and should never be used for injection. do not use on the eyes. to avoid excessive systemic absorption, cetacaine topical anesthetic gel should not be applied to large areas of denuded or inflamed tissue. cetacaine topical anesthetic gel should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. tolerance may vary with status of the patient. cetacaine topical anesthetic gel should not be used under dentures or cotton rolls, as retention of the active gel ingredients under a denture or cotton roll could possibly cause an escharotic effect. routine precaution for the use of any topical anesthetic should be observed when using cetacaine topical anesthetic gel.

Drug Interactions:

Use in Pregnancy:

Use in pregnancy safe use of cetacaine topical anesthetic gel has not been established with respect to possible adverse effects upon fetal development. therefore, cetacaine topical anesthetic gel should not be used during early pregnancy, unless in the judgement of a physician, the potential benefits outweigh the unknown hazards. routine precaution for the use of any topical anesthetic should be observed when cetacaine topical anesthetic gel is used.

Description:

Active ingredients: in a base consisting of polyethylene glycol, purified water, saccharin, cetyldimethylethylammonium bromide, flavoring and color benzocaine 14.0% butamben 2.0% tetracaine hydrochloride 2.0%

Mechanism of Action:

Action the onset of cetacaine topical anesthetic gel 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 hcl and bridged by the intermediate action of butamben. it is believed that all of these agents act by reversibly blocking nerve conduction. 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.

How Supplied:

How supplied cetacaine topical anesthetic gel (strawberry), 32 g jar ndc 10223-0217-3 item# 0217 cetacaine topical anesthetic gel (mint), 32 g jar ndc 10223-0221-1 item# 0221

Package Label Principal Display Panel:

Principal display panel - 32 g jar box - strawberry ndc 10223-0217-3 item# 0217 cetacaine Â® topical anesthetic gel (14% benzocaine, 2% butamben, and 2% tetracaine hydrochloride) indicated for anesthesia of all accessible mucous membrane except the eyes. strawberry flavor net contents: 32 g rev. 02/17 principal display panel - 32 g jar box - strawberry

Principal display panel - 32 g jar box - mint ndc 10223-0221-1 item# 0221 cetacaine Â® topical anesthetic gel (14% benzocaine, 2% butamben, and 2% tetracaine hydrochloride) indicated for anesthesia of all accessible mucous membrane except the eyes. cool mint flavor net contents: 32 g rev. 02/17 principal display panel - 32 g jar box - mint

Comments/ Reviews:

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