MedPath

Cetacaine Anesthetic

Cetacaine Topical Anesthetic Spray and Liquid

Approved
Approval ID

89f262a4-a41b-41d7-806b-61b9b89542f0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 11, 2023

Manufacturers
FDA

Cetylite Industries, Inc.

DUNS: 001283704

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzocaine, Butamben, and Tetracaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10223-0226
Product Classification
G
Generic Name
Benzocaine, Butamben, and Tetracaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 11, 2023
FDA Product Classification

INGREDIENTS (7)

Tetracaine HydrochlorideActive
Quantity: 0.004 g in 0.2 g
Code: 5NF5D4OPCI
Classification: ACTIB
ButambenActive
Quantity: 0.004 g in 0.2 g
Code: EFW857872Q
Classification: ACTIB
BenzocaineActive
Quantity: 0.028 g in 0.2 g
Code: U3RSY48JW5
Classification: ACTIB
Dipropylene glycolInactive
Code: E107L85C40
Classification: IACT
Benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
SaccharinInactive
Code: FST467XS7D
Classification: IACT
Mecetronium BromideInactive
Code: 7ZNQ7FIO9K
Classification: IACT

Benzocaine, Butamben, and Tetracaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10223-0202
Product Classification
G
Generic Name
Benzocaine, Butamben, and Tetracaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 11, 2023
FDA Product Classification

INGREDIENTS (7)

BenzocaineActive
Quantity: 0.028 g in 0.2 g
Code: U3RSY48JW5
Classification: ACTIB
ButambenActive
Quantity: 0.004 g in 0.2 g
Code: EFW857872Q
Classification: ACTIB
Tetracaine HydrochlorideActive
Quantity: 0.004 g in 0.2 g
Code: 5NF5D4OPCI
Classification: ACTIB
Benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Mecetronium BromideInactive
Code: 7ZNQ7FIO9K
Classification: IACT
SaccharinInactive
Code: FST467XS7D
Classification: IACT
Dipropylene glycolInactive
Code: E107L85C40
Classification: IACT

Benzocaine, Butamben, and Tetracaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10223-0225
Product Classification
G
Generic Name
Benzocaine, Butamben, and Tetracaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 11, 2023
FDA Product Classification

INGREDIENTS (7)

BenzocaineActive
Quantity: 0.028 g in 0.2 g
Code: U3RSY48JW5
Classification: ACTIB
ButambenActive
Quantity: 0.004 g in 0.2 g
Code: EFW857872Q
Classification: ACTIB
Tetracaine HydrochlorideActive
Quantity: 0.004 g in 0.2 g
Code: 5NF5D4OPCI
Classification: ACTIB
SaccharinInactive
Code: FST467XS7D
Classification: IACT
Benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Dipropylene glycolInactive
Code: E107L85C40
Classification: IACT
Mecetronium BromideInactive
Code: 7ZNQ7FIO9K
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/11/2023

PRINCIPAL DISPLAY PANEL - 24 g Bottle Kit

NDC 10223-0226-1
ITEM NO: 0226

Cetacaine®
TOPICAL ANESTHETIC LIQUID CLINICAL KIT
(Benzocaine 14.0%, Butamben 2.0%, and Tetracaine HCl 2.0%)

Featuring a Unique Dispenser Cap for Accurate Filling of Luer-lock Syringes

KIT CONTAINS:

1 24g bottle of Cetacaine Liquid

1 Luer-lock dispenser cap

100 Microcapillary Delivery Tips

100 Delivery Syringes

CETYLITE®

Rx Only

CAUTION: Not for injection. Do not use on the eyes. Keep out of reach of children.

PRINCIPAL DISPLAY PANEL - 24 g Bottle Kit

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/11/2023

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 brush 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 drop-wise 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.

INFORMATION FOR PATIENTS SECTION

LOINC: 34076-0Updated: 5/11/2023

PATIENT COUNSELING INFORMATION

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Hypersensitivity Reactions

Unpredictable adverse reactions (i.e. hypersensitivity, 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, Cetacaine preparations should not be applied for prolonged periods except under continual supervision. Dehydration of the epithelium or an escharotic effect may also result from prolonged contact.

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.

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Cetacaine Anesthetic - FDA Drug Approval Details