ULTRACARE ® Oral Anesthetic Gel

Manufacturer
Ultradent Products, Inc.
Effective date
2018-06-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:53:19

Label at a glance#

ProductUltraCare Oral Anesthetic Butter Rum
Active ingredientBenzocaine
Label structure13 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20% w/v

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

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

OTC - DO NOT USE SECTION

  • if tamper-evident seal is broken. Store at room temperature.

Warning

WARNINGS SECTION

  • For external use only.

Allergy alert

SPL UNCLASSIFIED SECTION

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

OTC - STOP USE SECTION

  • 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

OTC - WHEN USING SECTION

  • avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

SPL UNCLASSIFIED SECTION

Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and olderApply (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 ageShould be supervised in the use of this product.
Children under 2 years of ageConsult a dentist or a doctor.

Other

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Phenylketonurics: Contains Phenylalanine 3mg per gram.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

artificial flavor, aspartame, ethyl alcohol, FD&C red #40, FD&C blue #2, FD&C yellow #5, FD&C yellow #6, glycerin, polyethylene glycol, sodium saccharin.

SPL UNCLASSIFIED SECTION

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

SPL MEDGUIDE SECTION

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:

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

Procedure:

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

Precautions:

  • Do not use Ultracare on patients with history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
  • Ultracare is NOT for injection.
  • 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.
  • 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.
FigureFigure
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.

FigureFigure

© 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultracare®
ORAL ANESTHETIC GEL

Butter Rum

30ml REF/UP 312

ULTRADENT
PRODUCTS, INC.

Principal Display Panel - 30ml Label
Principal Display Panel - 30ml Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzocaineACTIVE MOIETYU3RSY48JW51
AlcoholINACTIVE INGREDIENT3K9958V90M1
AspartameINACTIVE INGREDIENTZ0H242BBR11
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Polyethylene GlycolINACTIVE INGREDIENT3WJQ0SDW1A1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51206-20351206-203-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 187 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1GRANULE, EFFERVESCENT / ORAL30 mgExact identifier — unii candidate
19 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1POWDER, FOR SUSPENSION / ORAL420 mgExact identifier — unii candidate
19 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1GRANULE, FOR SUSPENSION / ORAL420 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1SYRUP / ORAL0.63 mg/5mlExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET / ORAL87 mgExact identifier — unii candidate
19 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1LOZENGE / ORAL136 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL78 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
353b4bec-0f2e-4d95-ba0e-510fa49d6ebe1eb1b7dc-619a-4e0d-8a32-a4380c1522742018-06-18WarningsExact identifier
spl id: 353b4bec-0f2e-4d95-ba0e-510fa49d6ebe
spl set id: 1eb1b7dc-619a-4e0d-8a32-a4380c152274

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.