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| Product NDC Code | 51206-202 | ||||||||
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| Drug Name | Ultracare oral anesthetic walterberry |
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| Type | Brand | ||||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | DENTAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 238910, 1045348 |
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| Application Number | part356 | ||||||||
| Labeler Name | Ultradent Products, Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzocaine 20% w/v
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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. 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aspartame, D&C red no. 28, ethyl alcohol, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, sodium saccharin
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.UltraCare Oral Anesthetic Walterberry Benzocaine Benzocaine Benzocaine Polyethylene Glycol, Unspecified Glycerin Aspartame Saccharin Sodium Alcohol FD&C Red NO. 40 D&C Red NO. 28 Dark red Walterberry
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 30 mL Syringe Label 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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Manufactured by Ultradent Products, Inc. 505 West Ultradent Drive (10200 South), South Jordan, UT 84095
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if taking sulfonamides for teething in children under 2 years of age
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 800.552.5512
Spl medguide
Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.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: 1. Preloaded 1.2ml syringes: a. Remove luer lock cap from syringe. b. Attach a Blue Micro® 20-gauge Tip or 5mm Micro Capillary Tip securely onto syringe. c. Slowly express gel to the target tissue. d. For anesthetizing periodontal pockets: i. 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 Hold plunger in palm of hand for optimum control. Fig. 2 Deliver Ultracare from the large, no-waste IndiSpense syringe to cotton applicator, cotton roll, etc., for placement. 2. IndiSpense ® delivery: a. Remove cap from IndiSpense syringe. b. 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. c. 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: a. 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. b. With palm, press plunger of IndiSpense syringe gently while guiding the 1.2ml plunger outward to desired fill. c. RE-cap the IndiSpense syringe after each use. d. 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: 1. For Professional use only. 2. For external use only. 3. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 4. Ultracare is NOT for injection. 5. Pregnancy and Lactation: Safety is not known in pregnancy/nursing women. 6. Avoid contact with eyes. 7. 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. 8. If an excessive amount of gel is swallowed, get medical help or contact a Poison Control Center immediately. 9. Do not exceed maximum recommended dosage. 10. Phenylketonurics: Contains Phenylalanine—3mg per gram 11. See state or country guidelines for proper disposal of empty jar, syringes, applicator and tips. 12. 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. 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. © 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 Fig. 1 Fig. 2 Figure Key
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| 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. |
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes.
Storage and handling
Information about safe storage and handling of the drug product.Other information Phenylketonurics: Contains Phenylalanine 3 mg per gram Do not use if tamper-evident seal is broken Store at room temperature
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. Do not use if taking sulfonamides for teething in children under 2 years of age When using this product avoid contact with eyes. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API