TOPICAL ANESTHETIC- benzocaine gel, dentifrice

Topical Anesthetic by

Drug Labeling and Warnings

Topical Anesthetic by is a Prescription medication manufactured, distributed, or labeled by Patterson Dental, DSHealthcare, DENTSPLY Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INGREDIENTS

Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

CAUTION

Contains FD&C Yellow #5 (tartrazine) which may cause an allergenic response. Federal law prohibits dispensing without a prescription.

WARNING

Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.

HOW SUPPLIED

Store at controlled room temperature 59-86°F (15-30°C).

SPL UNCLASSIFIED SECTION

MADE IN U.S.A.

Distributed by:

PATTERSON
DENTAL
Corporate Office
1031 Mendota Heights Road
Saint Paul, MN 55120

PATTERSON
DENTAL /
Montréal Québec
H3M 3E6

PRINCIPAL DISPLAY PANEL - 29.6 mL Label

PATTERSON
DENTAL

Topical Anesthetic

Banana Flavor Gel
Contains 20% Benzocaine

For Professional Use Only
Net Contents 1 fl oz (29.6 mL)

Reorder Number
089-9989

INGREDIENTS AND APPEARANCE

TOPICAL ANESTHETIC   BANANA
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50227-2116
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	BANANA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50227-2116-1	34 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	02/19/1963

Labeler - Patterson Dental (171843584)

Registrant - DSHealthcare (056296981)

Establishment
Name	Address	ID/FEI	Business Operations
DENTSPLY Caulk		083235549	MANUFACTURE