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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated September 23, 2013

If you are a consumer or patient please visit this version.

  • 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 Flavor

  • Bubble Gum Package label

    Bubble Gum Flavor

  • Cherry

    Cherry Flavor

  • Mint

    Mint Flavor

  • Pina Colada

    Pina Collada

  • INGREDIENTS AND APPEARANCE
    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)