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Ultracare Anesthetic (Ultradent Products, Inc.)

Available Formats

Dosage Form Package Information Links
GEL 1 BOTTLE in 1 BOX (51206-201-01) > 30 mL in 1 BOTTLE Label Information
GEL 1 SYRINGE, PLASTIC in 1 BOX (51206-201-02) > 30 mL in 1 SYRINGE, PLASTIC Label Information

Complete Ultracare Anesthetic Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredient

    Benzocaine 20% w/v


  • Purpose

    Oral Anesthetic


  • INDICATIONS & USAGE

    Uses for the temporary relief of occasional minor irritation and pain, associated with:

    • minor dental procedures
    • sore mouth and throat
    • minor injury of the gums
    • canker sores
    • minor irritation of the mouth or gums caused by dentures or orthodontic appliances.

  • DO NOT USE

    Do not use:

    • if tamper-evident seal is broken.

    Store at room temperature.


  • Warning

    • For external use only.

    Allergy alert

    Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

    Stop use and ask a doctor

    • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting
    • if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.

    When using this product

    • avoid contact with eyes.

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.


  • DOSAGE & ADMINISTRATION

    Do not exceed recommended dosage.


  • Directions

    Adults and children 2 years of age and older Apply (a thin film) to affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily as directed by a dentist or doctor.
    Children under 12 years of age Should be supervised in the use of this product.
    Children under 2 years of age Consult a dentist or a doctor.

  • Other

    Phenylketonurics: Contains Phenylalanine 3mg per gram.


  • Inactive Ingredients

    aspartame, ethyl alcohol, FD&C red #40, glycerin, natural and artificial flavors, polyethylene glycol, sodium saccharin, titanium dioxide.


  • QUESTIONS

    Questions or comments? 1-800-552-5512 or www.ultradent.com
    Ultradent Products Inc, 505 West 10200 South, South Jordan, Utah 84095


  • MEDICATION GUIDE

    ULTRACARE®
    Oral Anesthetic Gel

    Description:

    Ultracare is a 20% benzocaine w/v (oral anesthetic gel) preparation in a water-soluble glycol base. It is available in 30ml bottles, 1.2ml single dose syringes, and in 30ml IndiSpense® container syringes. Special flavoring and sweetening agents are incorporated to render flavors of superior taste (with no aftertaste). Ultracare is designed for rapid onset (10-30 seconds). Anesthesia usually lasts 8-10 minutes. Benzocaine has been shown to be a safe, effective anesthetic with little or no systemic absorption. The incidence of allergic reaction is rare. Ultracare is NOT for injection.

    Uses:

    For the temporary relief of occasional minor irritation and pain, associated with:

    • minor dental procedures
    • sore mouth and throat
    • minor injury of the gums
    • canker sores
    • minor irritation of the mouth or gums caused by dentures or orthodontic appliances.

    Preliminary Steps:

    1.
    • For preloaded 1.2ml syringes:
    a.
    • Remove luer lock cap from syringe.
    b.
    • Twist a Blue Micro ® tip or 5mm Micro Capillary tip securely onto syringe.
    c.
    • Hold syringe in palm of hand (as shown in Fig. 1) for greater control, rather than in conventional manner with thumb on plunger.
    2.
    • For delivery from 30ml bottle:
    a.
    • Remove lid.
    b.
    • Dip cotton applicator in anesthetic.
    3.
    • For IndiSpense delivery to cotton applicator:
    a.
    • Remove cap from syringe.
    b.
    • Express desired amount of anesthetic to cotton applicator (Fig. 2).0
    4.
    • For IndiSpense delivery to empty 1.2ml syringe:
    a.
    • Attach a 1.2ml syringe to the end of IndiSpense by turning the luer lock of syringe snugly onto male thread of Indispense syringe.
    b.
    • With palm, press plunger of IndiSpense syringe gently while slowly pulling plunger of syringe out.
    c.
    • Attach tip to end of 1.2 ml syringe for delivery.
    5.
    • For IndiSpense delivery to dappen dish:
    a.
    • Remove cap from syringe.
    b.
    • Express desired amount of anesthetic to dappen dish. Dip cotton applicator in dappen dish. This allows for reapplication and eliminates/reduces potential for cross-contamination.
    Figures

    Procedure:

    1.
    • Vacuum excess saliva from mouth.
    2.
    • Deliver a controlled amount of Ultracare to desired area.

    Precautions:

    1.
    • Do not use Ultracare on patients with history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
    2.
    • Ultracare is NOT for injection.
    3.
    • The 1.2ml syringe size is designed for one-per-patient usage. Dispose syringe and tip following use, or use Ultradent ® Syringe Covers sealed with the Impulse Sealer to prevent cross-contamination.
    4.
    Phenylketonurics: Contains Phenylalanine—3mg per gram.
    Keep out of reach of children.
    Store at room temperature.
    For immediate reorder and/or complete descriptions of Ultradent's product line, refer to Ultradent's catalog
    or call Toll Free: 1-800-552-5512.
    Outside U.S. call (801) 572-4200.
    Figure
    All Ultradent syringes have an expiration date stamped on the side of the syringe consisting of one letter and three numbers. The letter is a lot number used for manufacturing purposes and the three numbers are the expiration date. The first two numbers are the month, and the third number is the last number of the year.

    Figure

    © Copyright 2000 Ultradent Products, Inc. All Rights Reserved.

    Ultradent Products, Inc.
    505 West 10200 South,
    South Jordan, Utah 84095, USA

    #10057.7

    032107


  • PRINCIPAL DISPLAY PANEL - 30ml Label

    Ultracare®
    ORAL ANESTHETIC GEL

    Bubble Gum

    30ml REF/UP 302

    ULTRADENT
    PRODUCTS, INC.

    Principal Display Panel - 30ml Label

  • INGREDIENTS AND APPEARANCE
    ULTRACARE ANESTHETIC   BUBBLE GUM
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51206-201
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 6.96 g  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Glycerin (UNII: PDC6A3C0OX)  
    Aspartame (UNII: Z0H242BBR1)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Alcohol (UNII: 3K9958V90M)  
    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:51206-201-01 1 in 1 BOX
    1 30 mL in 1 BOTTLE
    2 NDC:51206-201-02 1 in 1 BOX
    2 30 mL in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 06/01/1986
    Labeler - Ultradent Products, Inc. (013369916)
    Establishment
    Name Address ID/FEI Business Operations
    Ultradent Products, Inc. 013369916 MANUFACTURE, ANALYSIS, LABEL