Cetacaine Topical Spray Clinical Information
Gen. Code and Des.
48532 tetracaine/benzocaine/butamben TOPICAL SPRAY 2%-14%-2%
GCN and Des.
14011 tetracaine/benzocaine/butamben TOPICAL SPRAY 2%-14%-2%
Strength
Dose Form
AEROSOL, SPRAY (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84080000 ANTIPRURITICS AND LOCAL ANESTHETICS
Active Ingredients
1361 tetracaine 94246
1366 benzocaine 94097
1368 butamben 94257
Inactive Ingredients
2468 propylene glycol 57556
2600 saccharin 81072
3141 benzalkonium chloride 8001545
Rx Only
DESCRIPTION
Active Ingredients: in a base consisting of polyethylene glycol, purified water, saccharin, cetyldimethylethylammonium bromide, flavoring and ...
Action
The onset of Cetacaine Topical Anesthetic Gel produced anesthesia is rapid (approximately 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed. This effect ...
Indications
Cetacaine Topical Anesthetic Gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Topical Anesthetic Gel is indicated ...
Dosage and Administration
Only a limited quantity of Cetacaine Topical Anesthetic Gel is required for anesthesia. Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently depressing the pump ...
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 ...
DRUG INTERACTIONS
Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing ...
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 ...
Contraindications
Do not use Cetacaine Gel 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 ...
How Supplied
Cetacaine Topical Anesthetic Gel (Strawberry), 32 g jar - NDC 10223-0217-3 - Item# 0217 - Cetacaine Topical Anesthetic Gel (Mint), 32 g jar - NDC 10223-0221-1 - Item# 0221
SPL UNCLASSIFIED SECTION
Made in USA - Cetylite Industries, Inc. Pennsauken, NJ 08110 - www.cetacaine.com - Rev. 10/18
PRINCIPAL DISPLAY PANEL - 32 g Jar Box - Strawberry
NDC 10223-0217-3 - Item# 0217 - Cetacaine® Topical Anesthetic GEL - (14% Benzocaine, 2% Butamben, and 2% Tetracaine Hydrochloride) Indicated for anesthesia of all - accessible mucous membrane - except ...
PRINCIPAL DISPLAY PANEL - 32 g Jar Box - Mint
NDC 10223-0221-1 - Item# 0221 - Cetacaine® Topical Anesthetic GEL - (14% Benzocaine, 2% Butamben, and 2% Tetracaine Hydrochloride) Indicated for anesthesia of all - accessible mucous membrane - except ...
INGREDIENTS AND APPEARANCE
Product Information
