Ultracare Anesthetic

Ultradent Products, Inc.

ULTRACARE Oral Anesthetic Gel

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient
• Purpose
• Ultracare Anesthetic Uses
• Do not use
• Warning
  • Allergy alert
  • Stop use and ask a doctor
  • When using this product
• Directions
• Other
• Inactive Ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - 30ml Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Benzocaine 20% w/v

Purpose

Oral Anesthetic

Ultracare 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 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, D&C red #28, glycerin, natural and artificial flavors, polyethylene glycol, sodium saccharin.

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:

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.

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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.

© 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

Walterberry ^®

30ml REF/UP 301

ULTRADENT
PRODUCTS, INC.

Ultracare Anesthetic Benzocaine GEL Product Information Product Type Human otc drug label Item Code (Source) NDC:51206-202 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE Benzocaine 6.96 g Inactive Ingredients Ingredient Name Strength polyethylene glycol GLYCERIN ASPARTAME saccharin sodium ALCOHOL FD&C RED NO. 40 D&C RED NO. 28 Product Characteristics Color RED (Dark red) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE 2 30 in 1 SYRINGE, PLASTIC 3 NDC:51206-202-05 1.2 in 1 SYRINGE, PLASTIC 4 0.4 in 1 SYRINGE, PLASTIC 5 NDC:51206-202-03 1 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part356 1993-06-01