FDA.reportPublic FDA data

UltraCare

Manufacturer
Ultradent Products, Inc.
Effective date
2021-04-01
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 22:47:58

Label at a glance#

ProductUltraCare Oral Anesthetic Walterberry
Active ingredientBenzocaine
Label structure12 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 or as directed by your dentist or doctor. Children between 2 and 12 years of age: Should be supervised in the use of this product. Children under 2 years of age: Do not use.

Storage and handling

Phenylketonurics: Contains Phenylalanine 3 mg per gram Do not use if tamper-evident seal is broken Store at room temperature

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.

Warnings

WARNINGS SECTION

Methemoglobinemia warning

SPL UNCLASSIFIED SECTION

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy.

SPL UNCLASSIFIED 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, PABA compounds, or sunscreen. If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsens, see your dentist or doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • if taking sulfonamides
  • for teething
  • in children under 2 years of age

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. in case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

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 or as directed by your dentist or doctor.

  • Children between 2 and 12 years of age: Should be supervised in the use of this product.
  • Children under 2 years of age: Do not use.

Other information

STORAGE AND HANDLING SECTION

  • Phenylketonurics: Contains Phenylalanine 3 mg per gram
  • Do not use if tamper-evident seal is broken
  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, D&C red no. 28, ethyl alcohol, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

800.552.5512

SPL UNCLASSIFIED SECTION

Manufactured by Ultradent Products, Inc.
505 West Ultradent Drive (10200 South), South Jordan, UT 84095

SPL MEDGUIDE SECTION

Ultracare®
ORAL ANESTHETIC GEL

 

Description:

Ultracare is a 20% w/v (17.9%) benzocaine oral anesthetic gel preparation in a water-soluble glycol base. Ultracare is designed for rapid onset (10-30 seconds). Anesthesia usually lasts 8-10 minutes. 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

Warnings:

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy.

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, PABA compounds, or sunscreen. If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsens, see your dentist or doctor promptly.

Procedure:

  • Preloaded 1.2ml syringes:
    • Remove luer lock cap from syringe.
    • Attach a Blue Micro® 20-gauge Tip or 5mm Micro Capillary Tip securely onto syringe.
    • Slowly express gel to the target tissue.
    • For anesthetizing periodontal pockets:
      • Slowly apply a small amount to one quadrant at a time to the gingival margin or directly into the periodontal pockets and proceed with sub-gingival scaling.

Fig. 1Fig. 1

Fig. 1 Hold plunger in palm of hand for optimum control.

Fig. 2Fig. 2

Fig. 2 Deliver Ultracare from the large, no-waste IndiSpense syringe to cotton applicator, cotton roll, etc., for placement.
  • IndiSpense® delivery:
    • Remove cap from IndiSpense syringe.
    • Express desired amount of anesthetic to cotton applicator (Fig. 2) or into a dappen dish. Use a clean applicator with each area application. Re-cap the IndiSpense syringe after each use.
    • Using a dappen dish allows for re-application with the same applicator without the risk of cross-contamination. Re-cap the IndiSpense syringe after each use.
  • IndiSpense delivery to empty 1.2ml syringe:
    • Attach a 1.2ml syringe to the end of IndiSpense by turning the luer lock of the 1.2ml syringe snugly onto male thread of Indispense syringe.
    • With palm, press plunger of IndiSpense syringe gently while guiding the 1.2ml plunger outward to desired fill.
    • RE-cap the IndiSpense syringe after each use.
    • See instruction for 1.2ml syringe use.

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 or as directed by your dentist or doctor.
  • Rinse and expectorate to clear the oral cavity of residual product.
  • Apply a thin film to injection site(s) allowing the gelled cotton applicator to remain in place at least 1 minute.
  • Rinse and suction the oral cavity and continue with administering local anesthetic or with dental procedure.

For anesthetizing periodontal pockets:

  • See instruction for 1.2ml use.

Children between 2 and 12 years of age:

  • Should be supervised in the use of this product

Children under 2 years of age:

  • Do not use

Warnings and Precautions:

  • For Professional use only.
  • For external use only.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • Ultracare is NOT for injection.
  • Pregnancy and Lactation: Safety is not known in pregnancy/nursing women.
  • Avoid contact with eyes.
  • If applying intraorally from a syringe, verify flow on a gauze pad or mixing pad prior to applying. If resistance is met, replace tip and re-check.
  • If an excessive amount of gel is swallowed, get medical help or contact a Poison Control Center immediately.
  • Do not exceed maximum recommended dosage.
  • Phenylketonurics: Contains Phenylalanine—3mg per gram
  • See state or country guidelines for proper disposal of empty jar, syringes, applicator and tips.
  • To avoid cross-contamination of the prefilled syringes, use a disposable syringe cover, re-cap, and wipe syringe with an intermediate disinfectant between uses. If these measures are not taken, the syringes should be considered single-use. Tips are disposable. To avoid cross-contamination, do not re-use tips.
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.
KeyKey

© 2018 Ultradent Products, Inc. All Rights Reserved. Made in U.S.A.
Manufactured by Ultradent Products, Inc. 505 West Ultradent Drive, (10200 South) South Jordan, UT 84095 10057.18 052318

PRINCIPAL DISPLAY PANEL - 30 mL Syringe Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultracare®
Oral Anesthetic Gel

Walterberry®

REF/UP 359

ULTRADENT
PRODUCTS, INC.

1.01 FL OZ (30 mL) IndiSpense®

Made in USA | 33325.15 061318

PRINCIPAL DISPLAY PANEL - 30 mL Syringe Label
PRINCIPAL DISPLAY PANEL - 30 mL Syringe Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzocaineACTIVE MOIETYU3RSY48JW51
AlcoholINACTIVE INGREDIENT3K9958V90M1
AspartameINACTIVE INGREDIENTZ0H242BBR11
D&C Red NO. 28INACTIVE INGREDIENT767IP0Y5NH1
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOA1
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 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51206-20251206-202-01, 51206-202-02, 51206-202-03, 51206-202-04, 51206-202-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BenzocaineU3RSY48JW5ACTIB
Polyethylene Glycol, Unspecified3WJQ0SDW1AIACT
GlycerinPDC6A3C0OXIACT
AspartameZ0H242BBR1IACT
Saccharin SodiumSB8ZUX40TYIACT
Alcohol3K9958V90MIACT
FD&C Red NO. 40WZB9127XOAIACT
D&C Red NO. 28767IP0Y5NHIACT

Source Document#

Source XML · Source PDF

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 · 226 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Red NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Red NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C Red NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
D&C Red NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Red NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii candidate
28 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET / ORAL87 mgExact identifier — unii candidate
19 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 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
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Red NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, FOR SUSPENSION / ORAL15 mgExact identifier — unii candidate
19 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Red NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
D&C Red NO. 28D&C RED NO. 28767IP0Y5NHSUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1GRANULE, FOR SUSPENSION / ORAL420 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
D&C Red NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET / SUBLINGUAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
FD&C Red NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii candidate
28 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii candidate
19 equally ranked IID candidates
FD&C Red NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 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
19052b2e-209d-4151-a35c-2ee002fb4fdb87317d3c-ddda-403a-ad61-e2da9d50356a2021-04-01WarningsExact identifier
spl id: 19052b2e-209d-4151-a35c-2ee002fb4fdb
spl set id: 87317d3c-ddda-403a-ad61-e2da9d50356a

Reported adverse events (FAERS/openFDA)#

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