{"active_ingredient":["Active Ingredient Benzocaine 20% w/v"],"do_not_use":["Do not use if tamper-evident seal is broken. Store at room temperature."],"dosage_and_administration":["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."],"dosage_and_administration_table":["
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.
"],"effective_time":"20180618","id":"353b4bec-0f2e-4d95-ba0e-510fa49d6ebe","inactive_ingredient":["Inactive Ingredients 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."],"indications_and_usage":["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."],"keep_out_of_reach_of_children":["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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30ml Label Ultracare ® ORAL ANESTHETIC GEL Butter Rum 30ml REF/UP 312 ULTRADENT PRODUCTS, INC. Principal Display Panel - 30ml Label"],"purpose":["Purpose Oral Anesthetic"],"questions":["Questions or comments? 1-800-552-5512 or www.ultradent.com"],"set_id":"1eb1b7dc-619a-4e0d-8a32-a4380c152274","spl_medguide":["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. © Copyright 2000 Ultradent Products, Inc. All Rights Reserved. Ultradent Products, Inc. 505 West 10200 South, South Jordan, Utah 84095, USA #10057.7 032107 Figures Figure Figure"],"spl_medguide_table":["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.
1.a. b. c. 2.a. b. 3.a. b. 4.a. b. c. 5.a. b.
","
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.
"],"spl_product_data_elements":["UltraCare Oral Anesthetic Butter Rum Benzocaine Benzocaine Benzocaine Aspartame ALCOHOL FD&C Red No. 40 FD&C Blue No. 2 FD&C Yellow No. 5 FD&C Yellow No. 6 Glycerin POLYETHYLENE GLYCOL, UNSPECIFIED Saccharin Sodium Dark yellow to light brown Butter Rum Flavor"],"spl_unclassified_section":["Drug Facts","Other Phenylketonurics: Contains Phenylalanine 3mg per gram.","Ultradent Products Inc, 505 West 10200 South, South Jordan, Utah 84095"],"stop_use":["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."],"version":"3","warnings":["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."],"when_using":["When using this product avoid contact with eyes."]}