CETACAINE ANESTHETIC- benzocaine, butamben, and tetracaine hydrochloride aerosol, spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5), Butamben (UNII: EFW857872Q) (Butamben - UNII:EFW857872Q), Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV)

Available from:

Cetylite Industries, Inc.

INN (International Name):

Benzocaine

Composition:

Benzocaine 0.028 g in 0.2 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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. 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

Authorization status:

unapproved drug other

Summary of Product characteristics

CETACAINE ANESTHETIC- BENZOCAINE, BUTAMBEN, AND TETRACAINE
HYDROCHLORIDE AEROSOL, SPRAY
CETYLITE INDUSTRIES, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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CETACAINE
TOPICAL ANESTHETIC
SPRAY AND LIQUID
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.
RX ONLY.
Store at controlled room temperature 20-25°C (68-77°F)
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.
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.
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