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| Product NDC Code | 0404-0018 | ||||
|---|---|---|---|---|---|
| Drug Name | Benzo jel |
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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 | SPRAY, METERED | ||||
| RxCUI drug identifier | 360348, 1742420 |
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| Application Number | M006 | ||||
| Labeler Name | Henry Schein 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%
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 A single metered spray dispenses 50 mg of Benzo-Jel Topical Anesthetic. Use only as directed by a dentist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ethyl Alcohol, Flavor, Polyethelyn Glycol, Sodium Saccharin, Hydrocarbon Propellant (HFC-134a).
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 canker sores and minor dental procedures. For Professional Use Only.
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.Benzo Jel Benzocaine ALCOHOL POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM BENZOCAINE BENZOCAINE CLEAR
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
Label
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. In case of overdose, get medical help or contact a Poison Control Center nght away. Avoid spraying in eyes.
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? 1-800-472-4346
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.
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 setious condition that must be treated promptiy because it reduces the amount of oxygen canied in the blood. This can occur even if you have used this product before. Slop use and seek immediate medical attention tt you or a child in your care develops: • pale, gray or blue colored skn (cyanosis) • headache • rapid heart rate • shortress of breath • dizziness or lightheadedness • fatigue or lack of energy Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Flammable. Do not use near fire or flame. Avoid smoking during use. Do not use: for teething in children under 2 years of age
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