LOLLICAINE CHERRY- benzocaine gel, dentifrice LOLLICAINE MINT- benzocaine gel, dentifrice LOLLICAINE BUBBLE GUM- benzocaine gel, dentifrice LOLLICAINE PINA COLADA- benzocaine gel, dentifrice

Lollicaine Pina Colada by

Drug Labeling and Warnings

Lollicaine Pina Colada by is a Prescription medication manufactured, distributed, or labeled by Centrix, Inc., DENTSPLY Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOW SUPPLIED

Topical Anesthetic Gel 20% Benzocaine

Store at 59°F - 86°F (15°C - 30°C)

BUBBLE GUM          REF 360088 Contains 120 Lollipacks (.40g each)

CHERRY                  REF 360090 Contains 120 Lollipacks (.40g each)

MINT                      REF 360092 Contains 120 Lollipacks (.40g each)

PINA COLADA        REF 360094 Contains 120 Lollipacks (.40g each)

DESCRIPTION

LolliCaine is a flavored topical anesthetic gel featuring rapid onset, no systemic absorption, and 15-minute duration. LolliCaine is packaged in single-dose LolliPacks for maximum asepsis and ease of use. LolliPacks are also ideal to give to patients for take-home, post- operative topical pain relief. Each LolliPackunit contains one unit dose of LolliCaine gel plus swab applicator.

 INDICATIONS & USAGE

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 intraoral radiographs.

CONTRAINDICATIONS

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

WARNINGS

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

PRECAUTIONS

Avoid prolonged periods of storage at higher temperatures, it may cause degradation products.

ADVERSE REACTIONS

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with benzocaine gel. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); mouth burning, irritation, redness, swelling, or tenderness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

INGREDIENTs

INGREDIENTS: Each gram of LolliCaine 20% benzocaine gel contains 200mg of benzocaine

U.S.P. in a water soluble base of P.E.G. 3350 U.S.P., P.E.G. 400 U.S.P., flavor, sodium sac- charin U.S.P. and (cherry)[FD&C Red #40) (mint)[FD&C green #5)

.

SPL UNCLASSIFIED SECTION

Centrix Incorporated 770 River Road, Shelton, CT 06484 USA

Tel (203) 929-5582 Fax (203) 929-6804

Toll-Free (USA & Canada): (800) 235-5862

www.cenrtixdental.com

SPL UNCLASSIFIED SECTION

SECTION IV: Physical Data: Boiling point: higher than 250 Specific gravity: 1.091/25 Solubility in water: Disperse Viscosity: 164,000 Centipoise (Brookfield, spindle #6, 5 RPM) Appearance and odor: Gel with color and specified flavor Melting point: N/A

pH in water: 6.05

Vapor pressure: Negligible

SECTION V: FIRE AND EXPLOSION DATA: Flash point: Higher than 300 (Non-combustible liquid)

Extinguishing media: Water spray or carbon dioxide

Special fire-fighting procedures: Use self-contained breathing apparatus Unusual fire and explosion hazards: none

Effect of over-exposure: Inhalation of vapors may cause coughing and difficult breathing, contact with skin or eyes may cause irritation. Prolonged skin contact may cause dermati- tis. Ingestion may cause headache, nausea, vomiting, gastrointestinal irritation, convulsions, and unconsciousness

Emergency and first aid procedures: Flush skin and eye contact with water for 15 minutes. If swallowed, induce vomiting at once by giving 2 glasses of water and inserting finger down throat. Call a physician. Remove contaminated clothing and wash. Discard damaged clothing. Chronic effects of over-exposure: not identified.

SPL UNCLASSIFIED SECTION

Bubble Gum Package label

Cherry

Mint

Pina Colada

INGREDIENTS AND APPEARANCE

LOLLICAINE CHERRY 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 60640-3690
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

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: 60640-3690-1	120 in 1 BOX, UNIT-DOSE
1		0.4 g in 1 CUP, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/19/1963

LOLLICAINE MINT 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 60640-3692
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

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: 60640-3692-1	120 in 1 BOX, UNIT-DOSE
1		0.4 g in 1 CUP, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/19/1963

LOLLICAINE BUBBLE GUM 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 60640-3688
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

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: 60640-3688-1	120 in 1 BOX, UNIT-DOSE
1		0.4 g in 1 CUP, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/19/1963

LOLLICAINE PINA COLADA 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 60640-3694
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60640-3694-1	120 in 1 BOX, UNIT-DOSE
1		0.4 g in 1 CUP, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/19/1963

Labeler - Centrix, Inc. (053707303)

Registrant - Centrix, Inc. (053707303)

Establishment
Name	Address	ID/FEI	Business Operations
Centrix, Inc.		053707303	repack(60640-3690, 60640-3694, 60640-3692, 60640-3688)

Establishment
Name	Address	ID/FEI	Business Operations
DENTSPLY Caulk		083235549	manufacture(60640-3690)