TOPICAL ANESTHETIC BUBBLE GUM- benzocaine gel

Topical Anesthetic by

Drug Labeling and Warnings

Topical Anesthetic by is a Otc medication manufactured, distributed, or labeled by Safco Dental Supply Co.. 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 D&C Red #28.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

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).

INDICATIONS & USAGE

CAUTION

Federal law prohibits dispensing without a prescription.

SPL UNCLASSIFIED SECTION

Distributed by:
Safco Dental Supply Co.
Buffalo Grove, IL 60089
800-621-2178
www.safcodental.com

PRINCIPAL DISPLAY PANEL - Jar Label

SAFCO
SensiCaine

Topical Anesthetic Gel

Bubble Gum Flavor

Contains 20% Benzocaine

For Professional Use Only

1 oz. (34 g)

INGREDIENTS AND APPEARANCE

TOPICAL ANESTHETIC   BUBBLE GUM
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67239-0206
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Water (UNII: 059QF0KO0R)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67239-0206-1	34 g in 1 JAR; Type 0: Not a Combination Product	08/06/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	08/06/2012

Labeler - Safco Dental Supply Co. (020417380)

Registrant - Safco Dental Supply Co. (020417380)