TOPICAL ANESTHETIC PINA COLADA- benzocaine gel

Topical Anesthetic by

Drug Labeling and Warnings

Topical Anesthetic by is a Otc medication manufactured, distributed, or labeled by Patterson Dental Supply Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

INDICATIONS & USAGE

CAUTION

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
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

PATTERSON
DENTAL

NDC#50227-2110-1

Topical Anesthetic

Piña Colada Flavor Gel

Contains 20% Benzocaine

For Professional Use Only

Net Contents 1 fl oz (29.6 mL)

Reorder Number
090-0019

INGREDIENTS AND APPEARANCE

TOPICAL ANESTHETIC   PINA COLADA
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50227-2110
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 400 (UNII: B697894SGQ)
Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW (Opaque white to yellowish)	Score
Shape		Size
Flavor	PINEAPPLE (Pina Colada)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50227-2110-1	29.6 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 Supply Inc (171843584)