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| Product NDC Code | 66975-341 | ||||
|---|---|---|---|---|---|
| Drug Name | Bencocaine topical anesthetic |
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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, 1541816 |
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| Application Number | part356 | ||||
| Labeler Name | Benco Dental | ||||
| 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 Ingredients Benzocaine 200 mg (in each g)
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 • Apply only amount needed to the oral mucosa to prevent or relieve pain. • children under 2 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients flavoring, PEG 3350, PEG 400, 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.For oral mucosal use only, as directed by dentist. For the temporary relif of pain due to minor dental procedures.
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.BencoCaine Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 BENZOCAINE BENZOCAINE DYE-FREE
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.Bencocaine Topical Wrap_dye-free_99091791
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.Do not exceed recommended dosage If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Other Information Store at 59 -86°F(15-30°C). Protect from freezing.
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 •for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or worsens; or if swelling, rash or fever develops,see your physician promptly. • 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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Allergy Alert Allergy Alert Do not use on patients with a history of allergies to local anesthetics suchasprocaine,butacaine, benzocaine or other "caine" anesthetics.
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.GO.BENCO or benco.com
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. If contact occurs, flush with water.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, ask a physician before use.
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 Warnings Methemoglolllnemla warning: Use of this product may cause methemoglobinemia, a seriouscondit~n that must be treated promptly because tt reduces the amount of oxygen carried in the 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
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