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| Product NDC Code | 10129-072 | ||||
|---|---|---|---|---|---|
| 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 Belport Company, Inc. DBA Gingi-Pak | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.alert
Active ingredient
A list of the active, medicinal ingredients in the drug product.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.Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anethestic. Sterile cotton or gause should be used in applying anesthetic to mucosa. Care must be taken to avoid cross contamination between patients. Total dose should not exceed the amount required for anesthesia. Apply to the affected area. Remain in place for at least 1 minutes and then spit. Use up to 4 times daily or as directed by dentist or doctor. Do not exceed recommended dosage. This product is for adults and children 2 years or age and older. Children under 2 years of age should consult a dentist or a doctor. Dose admin
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.The inactive ingredients in UltraCare bubblegum are polyethylene glycol 400 (PEG 400) NF, Polyethylene Glycol 3350 (3350) NF, Sodium Saccharin, artificial Flavor, FD$C Red #40. Inactive
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 appliances. 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 appliances.
Purpose
Information about the drug product’s indications for use.Oral Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.UltraCare Anesthetic Gel Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 BENZOCAINE BENZOCAINE POTASSIUM SODIUM SACCHARATE
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.facts facts lable
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 doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharnx that might obtund protective reflexes. Stop use and ask doctor if sore throat is severe for 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. consult
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 ypersensitivity to any ester-type local anesthetics. Do not use the product for teething or in infants and children younger than 2 years dnu
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 keep out of reach of children
Safe handling warning
Safe Handling Warningstorage
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
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