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| Product NDC Code | 0699-7081 | ||||
|---|---|---|---|---|---|
| Drug Name | Topex mint |
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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, DENTIFRICE | ||||
| RxCUI drug identifier | 238910 | ||||
| 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 Mint
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.6. 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.4. CONTRAINDICATIONS Do not use onindividuals with a known sensitivity to benzocaine or PABA.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.7. DESCRIPTION Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.
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.2. DOSAGE AND ADMINISTRATION Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle Tightly re-cap the jar after each use.
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.3. DOSAGE FORMS AND STRENGTHS Each gram of Topex Topical Anesthetic Gel contains between 180-220 mg benzocaine in a flavored base.
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.1. INDICATIONS AND USAGE Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intraoral radiographs. Apply as required.
Spl product data elements
Usually a list of ingredients in a drug product.Topex Pina Colada Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM POLYETHYLENE GLYCOL 3350 Pina Colada Topex Cherry Benzocaine BENZOCAINE BENZOCAINE FD&C RED NO. 40 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM WATER POLYETHYLENE GLYCOL 400 Topex Mint Benzocaine BENZOCAINE BENZOCAINE D&C GREEN NO. 5 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM WATER PEPPERMINT OIL POLYETHYLENE GLYCOL 3350 Topex Bubble Gum Benzocaine BENZOCAINE BENZOCAINE D&C RED NO. 28 WATER POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM Topex Strawberry Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 WATER SACCHARIN SODIUM FD&C RED NO. 40 Topex Raspberry Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM FD&C RED NO. 40 D&C RED NO. 28 FD&C BLUE NO. 1 WATER Topex Cherry Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM WATER FD&C RED NO. 40 Topex Mint Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM WATER PEPPERMINT OIL D&C GREEN NO. 5 Topex Pina Colada Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 Pina Colada Topex Bubble Gum Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM WATER POLYETHYLENE GLYCOL 400 D&C RED NO. 28
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 - Cherry 34 Gram Cherry 1 oz
PRINCIPAL DISPLAY PANEL - Mint 34 gram Mint 1 oz
PRINCIPAL DISPLAY PANEL - Pina Colada 34 gram P Colada 1 oz
PRINCIPAL DISPLAY PANEL - Bubble Num 34 gram B Num 1 oz
PRINCIPAL DISPLAY PANEL - Strawberry 34 gram Strawberry 1 oz
PRINCIPAL DISPLAY PANEL - Razzberry 34 gram Razzberry 1 oz
PRINCIPAL DISPLAY PANEL - Cherry 100 gram Cherry 100 gram
PRINCIPAL DISPLAY PANEL - Mint 100 gram Mint 100 g
PRINCIPAL DISPLAY PANEL - Pina Colada 100 gram P Colada 100 g
PRINCIPAL DISPLAY PANEL - Bubble Num 100 gram B Num 100 g
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.DIRECTIONS FOR USE Gel – 1oz/30mL AD31001 Cherry AD31002 Mint AD31004 Pina Colada AD31005 Bubble-Num AD31006 Strawberry AD31007 Razzberry Gel – 100g jar AD31064 Cherry AD31964 Mint AD31067 Pina Colada AD31068 Bubble-Num For dental use only. Rx only.
MANUFACTURED FOR Sultan Healthcare 1301 Smile Way • York, PA 17404 • USA Toll Free: 800-637-8582 • Phone: 201-871-1232 Fax: 201-871-0321 • www.sultanhealthcare.com Made in the USA 0031001DF, R4-072017
Storage and handling
Information about safe storage and handling of the drug product.8. HOW SUPPLIED / STORAGE AND HANDLING Topex 20% benzocaine gel is supplied in multiple use containers. Store between 59°-86°F (15°-30°C). Protect from freezing.
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