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| Product NDC Code | 10129-071 | ||||
|---|---|---|---|---|---|
| Drug Name | Ultracare anesthetic gel |
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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, PERIODONTAL, TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 238910 | ||||
| Application Number | M022 | ||||
| Labeler Name | The Bellport Company, Inc. dba Gingi-Pak | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of UltraCare Anesthetic Gel
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.If more than normal usage amount if accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.
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.Dosage and Administration Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic. Sterile cotton or gauze should be used in applying anesthetic to mucosa. Care must be taken to avoid cross-contamination between patients. Total dose should not exceed the amout required for anethesia. - Apply to the affected area. - Remain in place for at least 1 minute and then spit. - Use up to 4 times daily or as directed by a dentist or doctor. - Do not exceed recommended dosage. - This product is for adultsand children 2 years of age and older. - Chidlren under 2 years of age should consult a dentist or a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Polyethylene Glycol 400 (PEG 400) NF, Polyethylene Glycol 3350 (3550) NF, Sodium Saccharin, natural and artificial flavors.
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 Reduce pain or discomfort caused by - minor dental procedures - minor gum injury - canker sores - sore throat - minor mouth or gum irritations caused by dentures or orthodontic applicances
Indications Anesthesia of mucous membrane of oropharynx. Minimizes the pain of ulcers, needle puncture, deep scaling procedures, and the application of matrix bands. Also an aid in the taking of impressions or intraoral radiographs of patients with an excessive gag reflexes.
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 Anesthetic Gel Benzocaine POLYETHYLENE GLYCOL 400 POTASSIUM SODIUM SACCHARATE POLYETHYLENE GLYCOL 3350 BENZOCAINE BENZOCAINE 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.UltraCare
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if - Sore throat is severe and more than 2 days - Fever, headache, rash, nausea, or vomiting develops - Mouth sore does not go away within 10 days - Irritation, pain or redness worsens
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes.
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 in patients with history of hypersensitivity to any ester-type local anesthetics. Do not use the product for teething or in infants and children younger than 2 years. Do not use if you have history of allergy to any "caine" local anesthetics. Avoid contact with eyes.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Inactive Ingredients Polyethylene Glycol 400 (PEG 400) NF, Polyethylene Glycol 3350 (3550) NF, Sodium Saccharin, natural and artificial flavors. Storage Avoid excessive heat above 40C (104F). Net content 1oz. (30 grams)
Storage and handling
Information about safe storage and handling of the drug product.Storage Avoid excessive heat above 40C (104F). Net content 1oz. (30 grams)
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 For external use only. Stop use and ask a doctor if - Sore throat is severe and more than 2 days - Fever, headache, rash, nausea, or vomiting develops - Mouth sore does not go away within 10 days - Irritation, pain or redness worsens Ask a doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes. Methemoglobinemia warning Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated prompltly because it reduces the amount of oxygen carried in blood. Cease use and seek immediate medical attention if one of the following symptoms develops: -Pale, gray, or blue colored skin (cyanosis) - Headache - Rapid heart rate - Shortness of breath _ Dizziness or lightheadedness - Fatigue or lack of energy Do not use in patients with history of hypersensitivity to any ester-type local anesthetics. Do not use the product for teething or in infants and children younger than 2 years. Do not use if you have history of allergy to any "caine" local anesthetics. Avoid contact with eyes. Keep out of reach of children. If more than normal usage amount if accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.
Methemoglobinemia warning Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated prompltly because it reduces the amount of oxygen carried in blood. Cease use and seek immediate medical attention if one of the following symptoms develops: -Pale, gray, or blue colored skin (cyanosis) - Headache - Rapid heart rate - Shortness of breath _ Dizziness or lightheadedness - Fatigue or lack of energy
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