Cetacaine Topical Anesthetic Gel

Generic Name: benzocaine, butamben and tetracaine hydrochloride
Dosage Form: gel

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.

Cetacaine® Topical Anesthetic GEL

Active Ingredients:
Benzocaine 14.0%
Butamben 2.0%
Tetracaine Hydrochloride 2.0%
Inactive Ingredients:
Benzalkonium Chloride 0.5%
Cetyl Dimethyl Ethyl
  Ammonium Bromide 0.005%
In a bland water-soluble base.

Rx Only.

Caution

Do not use in eyes. Keep out of reach of children.

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Directions

Read package insert. Press top of container to dispense desired amount. Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently depressing the pump. Dispensing a bead in excess of 400 mg is contraindicated. Spread thinly and evenly over the desired area using a cotton swab.

Item# 0217

Rev. 01/11

Manufactured by:
CETYLITE INDUSTRIES, INC.

9051 River Road
Pennsauken, NJ 08110
www.cetylite.com

PRINCIPAL DISPLAY PANEL - 32 g Jar Box

NDC 10223-0217-3

Cetacaine®
Topical Anesthetic GEL

(14% Benzocaine, 2% Butamben, and 2% Tetracaine Hydrochloride)

Indicated for anesthesia of all accessible
mucous membrane except the eyes.

Store in a cool dry place.

Net Wt. 32 g

CETACAINE TOPICAL ANESTHETIC 
benzocaine, butamben, and tetracaine hydrochloride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10223-0217
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
Polyethylene Glycols  
Saccharin  
Benzalkonium chloride  
Mecetronium bromide  
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:10223-0217-3 1 JAR in 1 BOX
1 32 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/1960
Labeler - Cetylite Industries, Inc. (001283704)
Establishment
Name Address ID/FEI Operations
Cetylite Industries, Inc. 001283704 MANUFACTURE(10223-0217), ANALYSIS(10223-0217), LABEL(10223-0217), PACK(10223-0217)
Revised: 08/2014
 
Cetylite Industries, Inc.



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