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| Product NDC Code | 83062-410 | ||||
|---|---|---|---|---|---|
| Drug Name | Dentek instant pain relief maximum strength |
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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 | LIQUID | ||||
| RxCUI drug identifier | 308657 | ||||
| Application Number | M022 | ||||
| Labeler Name | IIMED MEDICAL MEXICANA S. DE R.L. DE C.V | ||||
| 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.Directions dip applicator into liquid Adults and children 2 years of age and older: Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age: Should be supervised in the use of this product. Children under 2 years of age: Ask a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose
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 pain due to: toothaches canker sore cold sores sore gums
Purpose
Information about the drug product’s indications for use.Purpose Oral Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Dentek Instant Pain Relief Maximum Strength Benzocaine PEPPERMINT OIL SUCRALOSE SPEARMINT OIL POLYETHYLENE GLYCOL 400 BENZOCAINE BENZOCAINE Colorless to light yellow liquid
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.DenTek Instant Pain Relief Inner Vial Label Entire 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 In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information do not use if safety seal on carton is broken this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted do not use continuously
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? Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a dentist or doctor if swelling, rash or fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days
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 the eyes do not exceed recommended dosage do not use for more than 7 days unless than directed by a doctor/dentist
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 Allergy Alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. When using this product avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless than directed by a doctor/dentist Stop use and ask a dentist or doctor if swelling, rash or fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.
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