UltraCare

Manufacturer: Ultradent Products, Inc.
Effective date: 2021-04-01
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 22:48:03

Label at a glance#

ProductUltraCare Oral Anesthetic Bubble Gum

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

Contacts and useful links#

PhoneLabel contact800.552.5512

PhoneLabel contact(801) 572-4200

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.

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, ethyl alcohol, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, sodium saccharin, titanium dioxide

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:

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:

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:

1.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.
- d.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. 1

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

Fig. 2

Fig. 2 Deliver Ultracare from the large, no-waste IndiSpense syringe to cotton applicator, cotton roll, etc., for placement.

2.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.
3.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.

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.

Key

PRINCIPAL DISPLAY PANEL - 30 mL Syringe Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultracare^®
Oral Anesthetic Gel

Bubble Gum

REF/UP 357

ULTRADENT
PRODUCTS, INC.

1.01 FL OZ (30 mL) IndiSpense^®

Made in USA | 33329.14 062518

PRINCIPAL DISPLAY PANEL - 30 mL Syringe Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	1
Aspartame	INACTIVE INGREDIENT	Z0H242BBR1	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Polyethylene Glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

UltraCare Oral Anesthetic Bubble Gum
Benzocaine
Aspartame
Alcohol
FD&C Red No. 40
Glycerin
POLYETHYLENE GLYCOL, UNSPECIFIED
Saccharin Sodium
Titanium Dioxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51206-201	51206-201-01, 51206-201-02

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
Name	UNII	Kind
Benzocaine	U3RSY48JW5	ACTIB
Aspartame	Z0H242BBR1	IACT
Alcohol	3K9958V90M	IACT
FD&C Red No. 40	WZB9127XOA	IACT
Glycerin	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Titanium Dioxide	15FIX9V2JP	IACT

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 5 · 255 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Aspartame	ASPARTAME	Z0H242BBR1	POWDER, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Aspartame	ASPARTAME	Z0H242BBR1	FILM, EXTENDED RELEASE / BUCCAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Aspartame	ASPARTAME	Z0H242BBR1	SUSPENSION / ORAL		23 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Aspartame	ASPARTAME	Z0H242BBR1	TABLET, FILM COATED / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Aspartame	ASPARTAME	Z0H242BBR1	SOLUTION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ef1abc86-26ba-48a2-b40f-a2f4a5291545			fd4a668a-28eb-4abc-b944-d17da3397510	2021-04-01	Warnings	Exact identifier spl id: ef1abc86-26ba-48a2-b40f-a2f4a5291545 spl set id: fd4a668a-28eb-4abc-b944-d17da3397510

Reported adverse events (FAERS/openFDA)#

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