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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Lolicaine Topical Anesthetic Gel/Liquid –
20% Benzocaine

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)

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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

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.

Bubble Gum Flavor

Bubble Gum Package label

Bubble Gum Flavor

Cherry

Cherry Flavor

Mint

Mint Flavor

Pina Colada

Pina Collada

LOLLICAINE CHERRY 
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60640-3690
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60640-3690-1120 in 1 BOX, UNIT-DOSE
10.4 g in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
LOLLICAINE MINT 
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60640-3692
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60640-3692-1120 in 1 BOX, UNIT-DOSE
10.4 g in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
LOLLICAINE BUBBLE GUM 
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60640-3688
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60640-3688-1120 in 1 BOX, UNIT-DOSE
10.4 g in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
LOLLICAINE PINA COLADA 
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60640-3694
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorCOCONUT (Pina Coloda) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60640-3694-1120 in 1 BOX, UNIT-DOSE
10.4 g in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
Labeler - Centrix, Inc. (053707303)
Registrant - Centrix, Inc. (053707303)
Establishment
NameAddressID/FEIBusiness Operations
Centrix, Inc.053707303repack(60640-3690, 60640-3694, 60640-3692, 60640-3688)
Establishment
NameAddressID/FEIBusiness Operations
DENTSPLY Caulk083235549manufacture(60640-3690)

Revised: 9/2013
Document Id: 771e79ab-4ac6-4439-8630-bbf579259fbe
Set id: 8f1439e8-4b13-49e3-97c3-fbb565ef09c9
Version: 2
Effective Time: 20130923
 
Centrix, Inc.