Cetacaine Topical Anesthetic Spray

Name: Cetacaine Topical Anesthetic Spray

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 HCI 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.


PRINCIPAL DISPLAY PANEL - 20 g Bottle Box

NDC 10223-0201-3
Item No. 0220

Cetacaine®

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®
Cetylite Industries, Inc.
Pennsauken, NJ 08110-3293
www.cetylite.com

CETACAINE ANESTHETIC 
benzocaine, butamben, and tetracaine hydrochloride aerosol, spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10223-0201
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 0.028 g  in 0.2 g
Butamben (Butamben) Butamben 0.004 g  in 0.2 g
Tetracaine Hydrochloride (Tetracaine) Tetracaine Hydrochloride 0.004 g  in 0.2 g
Inactive Ingredients
Ingredient Name Strength
Dipropylene glycol  
Saccharin  
Benzalkonium chloride  
Mecetronium bromide  
Product Characteristics
Color      Score     
Shape Size
Flavor BANANA Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:10223-0201-1 1 BOTTLE, GLASS in 1 BOX
1 56 g in 1 BOTTLE, GLASS
2 NDC:10223-0201-3 1 BOTTLE, GLASS in 1 BOX
2 20 g in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/1958
Labeler - Cetylite Industries, Inc. (001283704)
Establishment
Name Address ID/FEI Operations
Cetylite Industries, Inc. 001283704 MANUFACTURE(10223-0201), ANALYSIS(10223-0201), LABEL(10223-0201), PACK(10223-0201)
Revised: 09/2015   Cetylite Industries, Inc.
(web3)