SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA- benzocaine gel SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM- benzocaine gel SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY- benzocaine gel SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY- benzocaine gel SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT- benzocaine gel SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY- benzocaine gel

SmartPractice topical anesthetic gel by

Drug Labeling and Warnings

SmartPractice topical anesthetic gel by is a Prescription medication manufactured, distributed, or labeled by SmartHealth, Inc. (DBA SmartPractice), Dentsply Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.

INDICATIONS

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs.

CONTRAINDICATIONS

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

WARNINGS

Keep out of reach of children. For professional dental use only.

PRECAUTIONS

SmartPractice 20% benzocaine gels are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.

DOSAGE AND ADMINISTRATION

1. Each gram of benzocaine gel between 180-220mg benzocaine in a flavored base.

2. Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle.

3. For topical tissue anesthesia during scaling procedures, dispense a small amount of gel into a dappen dish, then coat the scaler with the product prior to use.

4. Tightly re-cap the jar after each use.

STORAGE

Store between 59°-86°F (15°-30°C). Protect from freezing.

DISTRIBUTED BY

distributed by:
SmartPractice

3400 east mcdowell rd

phoenix, AZ 85008

Made in USA.

PRINCIPAL DISPLAY PANEL - Cherry

PRICIPAL DISPLAY PANEL - Mint

PRINCIPAL DISPLAY PANEL - Pina Colada

PRINCIPAL DISPL;AY PANEL - Bubble Gum

PRINCIPAL DISPLAY PANEL - Strawberry

PRINCIPAL DISPLAY PANEL - Raspberry

INGREDIENTS AND APPEARANCE

SMARTPRACTICE TOPICAL ANESTHETIC GEL  PINA COLADA
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69521-041
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 (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

Product Characteristics
Color		Score
Shape		Size
Flavor	COCONUT (Pina Colada)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69521-041-34	34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/19/1963

SMARTPRACTICE TOPICAL ANESTHETIC GEL  BUBBLE GUM
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69521-031
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 (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

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: 69521-031-34	34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/19/1963

SMARTPRACTICE TOPICAL ANESTHETIC GEL  STRAWBERRY
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69521-051
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 (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69521-051-34	34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/19/1963

SMARTPRACTICE TOPICAL ANESTHETIC GEL  CHERRY
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69521-021
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 (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69521-021-34	34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/19/1963

SMARTPRACTICE TOPICAL ANESTHETIC GEL  MINT
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69521-011
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
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69521-011-34	34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/19/1963

SMARTPRACTICE TOPICAL ANESTHETIC GEL  RASPBERRY
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69521-061
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 (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69521-061-34	34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/19/1963

Labeler - SmartHealth, Inc. (DBA SmartPractice) (061081477)

Establishment
Name	Address	ID/FEI	Business Operations
Dentsply Caulk		083235549	manufacture(69521-041, 69521-011, 69521-021, 69521-031, 69521-051, 69521-061)