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| Product NDC Code | 60630-077 | ||||
|---|---|---|---|---|---|
| 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, TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 308657 | ||||
| Application Number | part356 | ||||
| Labeler Name | DenTek Oral Care, 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.Directions dip applicator into liquid Adults and children 2 years 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 between 2 and 12 years Should be supervised in the use of this product. Children under 2 years Do not use.
| Adults and children 2 years 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 between 2 and 12 years | Should be supervised in the use of this product. |
| Children under 2 years | Do not use. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Peppermint Oil, Polyethylene Glycol 400, 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.Use for the temporary relief of pain due to: toothaches canker sores 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 BENZOCAINE BENZOCAINE PEPPERMINT OIL POLYETHYLENE GLYCOL 400 SPEARMINT OIL SUCRALOSE 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.PRINCIPAL DISPLAY PANEL Den T ek ™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE PRINCIPAL DISPLAY PANEL DenTek™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE PRINCIPAL DISPLAY PANEL DenTek™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE
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.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
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 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 for toothaches, use only as a temporary remedy until a dentist can be seen store at 20-25⁰C (68-77⁰F).
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 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 METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in 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 Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. Do not use for teething in children under 2 years of age When using this product avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless 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 (1-800-222-1222) 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