Cetacaine Anesthetic

Benzocaine, Butamben, And Tetracaine Hydrochloride

Cetylite Industries, Inc.
Human Prescription Drug
NDC 10223-0201

Cetacaine 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 Anesthetic is 10223-0201. This drug is available in dosage form of Aerosol, Spray. The names of the active, medicinal ingredients in Cetacaine Anesthetic drug includes Benzocaine - .028 g/.2g Butamben - .004 g/.2g Tetracaine Hydrochloride - .004 g/.2g . The currest status of Cetacaine Anesthetic drug is Active.

Drug Information:

Drug NDC:	10223-0201
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 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:	Aerosol, Spray
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, 1958
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:	999683 1722107
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:	U3RSY48JW5 EFW857872Q 5NF5D4OPCI
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
10223-0201-3	1 BOTTLE, GLASS in 1 BOX (10223-0201-3) / 20 g in 1 BOTTLE, GLASS	01 Jan, 2016	N/A	No
10223-0201-4	1 BOTTLE, GLASS in 1 BOX (10223-0201-4) / 5 g in 1 BOTTLE, GLASS	01 Nov, 2017	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 anesthetic benzocaine, butamben, and tetracaine hydrochloride benzocaine benzocaine butamben butamben tetracaine hydrochloride tetracaine dipropylene glycol saccharin benzalkonium chloride mecetronium bromide

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

Warnings and Cautions:

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 cetacaine spray should be applied for approximately one second or less for normal anesthesia. only a limited quantity of cetacaine is required for anesthesia. spray in excess of two seconds is contraindicated. each one-second spray contains an average of 200 mg of product, not including propellant. to apply, insert the cannula firmly onto the protruding plastic stem on the bottle and press the cannula forward to actuate the spray valve. the cannula may be removed and reinserted as many times as required for cleaning, or sterilization, and is autoclavable. cetacaine liquid apply 200 mg liquid (approximately 0.2 ml) directly to tissue. liquid in excess of 400 mg (approximately 0.4 ml) is contraindicated. to apply, remove and discard the shipping cap from the bottle. replace it with the supplied luer-lock cap. caution: do not over-tighten. remove small cap from luer-lock port, retaining it for replacement after use. port allows for a single dip of a cotton or bru Read more...

sh applicator for application directly to accessible mucous membrane. for application into periodontal pockets, cetylite luer-lock syringes and microcapillary delivery tips are recommended. cetylite syringes are clearly marked in (4) 0.1 ml increments. to fill, attach syringe to port by gently twisting clockwise until secure. invert and draw desired amount of liquid into the syringe. remove filled syringe and attach microcapillary delivery tip to the syringe. tip may be bent to improve access. apply dropwise to accessible mucous membrane (such as buccal and lingual sulcus) by slowly depressing the syringe plunger. discard all applicators after use. an appropriate pediatric dosage has not been established for cetacaine spray or cetacaine liquid. dosages should be reduced in the debilitated elderly, acutely ill, and very young patients (i.e., children 2 years and older). do not use cetacaine spray or cetacaine liquid to treat infants or children younger than 2 years. tissue need not be dried prior to application of cetacaine. cetacaine 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 cetacaine (spray or liquid) contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine hcl.

Contraindications:

Contraindications do not use cetacaine spray or cetacaine liquid 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 should not be applied to large areas of denuded or inflamed tissue. cetacaine 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 the status of the patient. cetacaine should not be used under dentures or cotton rolls, as retention of the active 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.

Drug Interactions:

Use in Pregnancy:

Use in pregnancy safe use of cetacaine has not been established with respect to possible adverse effects upon fetal development. therefore, cetacaine 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 is used.

Description:

Active ingredients benzocaine 14.0% butamben 2.0% tetracaine hydrochloride 2.0% contains benzalkonium chloride 0.5% cetyl dimethyl ethyl ammonium bromide 0.005% in a bland, water-soluble base.

Mechanism of Action:

Action the onset of cetacaine-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. 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 spray, 20 g bottle, including propellant warning cetacaine spray contains cfc-114 and cfc-11, substances which harm public health and environment by destroying ozone in the upper atmosphere. the propellant leak rate of cetacaine spray does not meet the usp requirements. (item # 0220, ndc 10223-0201-3) which includes one cannula. cetacaine spray single patient use, 5 g bottle, including propellant (item # 0222, ndc 10223-0201-4) which includes one cannula. cetacaine liquid chairside kit (item # 0218 ndc 10223-0202-6) which includes one 14 g bottle of cetacaine liquid with luer-lock dispenser cap, 20 syringes and 20 delivery tips. cetacaine liquid clinical kit (item # 0212, ndc 10223-0202-5) which includes one 30 g bottle of cetacaine liquid with luer-lock dispenser cap, 100 syringes and 100 delivery tips. cetacaine liquid, 14 g bottle (item # 0203, ndc 10223-0202-2) with luer-lock dispenser cap. cetacaine liquid, 30 g bottle (item # 0211, ndc 10223-0202-4) with lu Read more...

er-lock dispenser cap.

Package Label Principal Display Panel:

Principal display panel - 20 g bottle box ndc 10223-0201-3 item no. 0220 cetacaine Â® topical anesthetic spray control pain control gagging effective only on mucous membrane rx only exclusive spray cannula provides complete control (one cannula included) (benzocaine 14.0%, butamben 2.0%, tetracaine hydrochloride 2.0%) cetylite Â® cetylite industries, inc. pennsauken, nj 08110-3293 www.cetylite.com principal display panel - 20 g bottle box

Comments/ Reviews:

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