TOPICAL ANESTHETIC STRAWBERRY- 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 U.S.P., and FD&C Red #40.

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

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#50227-2111-1

Topical Anesthetic

Strawberry Flavor Gel

Contains 20% Benzocaine

For Professional Use Only

Net Contents 1 fl oz (29.6 mL)

Reorder Number
090-0027

INGREDIENTS AND APPEARANCE

TOPICAL ANESTHETIC   STRAWBERRY
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50227-2111
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	RED (Reddish pink)	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50227-2111-1	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)