Ultracare Anesthetic Pina Colada

Dosage form: gel
Ingredients: Benzocaine 6.96g in 30mL
Labeler: Ultradent Products, Inc.
NDC Code: 51206-204

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ULTRACARE®
Oral Anesthetic Gel

Drug Facts

Active Ingredient

Benzocaine 20% w/v

Purpose

Oral Anesthetic

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
  • 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.

Do not exceed recommended dosage.

Directions
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

Phenylketonurics: Contains Phenylalanine 3mg per gram.

Inactive Ingredients

artificial flavor, aspartame, ethyl alcohol, FD&C yellow #5, glycerin, polyethylene glycol, sodium saccharin, titanium dioxide.

Questions or comments?

1-800-552-5512 or www.ultradent.com

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

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.

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.
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.

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.

© 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

Piña Colada

30ml REF/UP 310

ULTRADENT
PRODUCTS, INC.

ULTRACARE ANESTHETIC  PINA COLADA
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-204
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine6.96 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 
Glycerin 
Aspartame 
Saccharin Sodium 
Titanium Dioxide 
Alcohol 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorCOCONUT (Pina Colada) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51206-204-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/01/1986
Labeler - Ultradent Products, Inc. (013369916)
Establishment
NameAddressID/FEIOperations
Ultradent Products, Inc.013369916MANUFACTURE, ANALYSIS, LABEL

Revised: 03/2010
 
Ultradent Products, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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