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| Product NDC Code | 0699-3100 | ||||
|---|---|---|---|---|---|
| Drug Name | Topex |
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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 | PERIODONTAL | ||||
| Dosage Form | SPRAY, METERED | ||||
| RxCUI drug identifier | 360348 | ||||
| Labeler Name | Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Topex
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE In case of overdose, get medical help or contact a Poison Control Center right away.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Should not be used in individuals with a known sensitivity to benzocaine or PABA.
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 Attach disposable straw to the spray valve. Spray directly on mucosa to achieve topical anesthesia.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.DOSAGE FORMS AND STRENGTHS Each gram of Topex 20% benzocaine topical anesthetic spray contains between 180-220 mg benzocaine. Each metered spray delivers approximately 6.8 mg of benzocaine.
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.INDICATIONS AND USAGE Topical anesthetic for use on oral mucosa
Spl product data elements
Usually a list of ingredients in a drug product.Topex benzocaine BENZOCAINE BENZOCAINE SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 BENZALDEHYDE APAFLURANE
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 - Carton Cherry carton
Storage and handling
Information about safe storage and handling of the drug product.STORAGE AND HANDLING Store between 59°-86°F (15°-30°C).
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