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| Product NDC Code | 60630-091 | ||||
|---|---|---|---|---|---|
| Drug Name | Dentek canker cover |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TRANSMUCOSAL | ||||
| Dosage Form | PATCH, EXTENDED RELEASE | ||||
| RxCUI drug identifier | 1725069, 1725075 |
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| Application Number | M022 | ||||
| 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 (per each patch) Menthol 2.5 mg
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 adults and children 5 years of age and older, apply up to 3 times a day, as needed The sore should be dry (pat with tissue) if possible. Place the patch on a clean, dry finger with the white side up. Place the white side on the sore and hold in place for 20 seconds. If sore is difficult to reach (in the fold between the cheek and gum or near the teeth or lip) break the patch along the score and use half. Some discomfort may occur during the first few minutes, but will quickly subside, followed by hours of soothing relief. Within 30 minutes the tablet forms a clear, gel-like bandage that seals and protects the sore for hours before dissolving. Do not remove the patch before it dissolves. In case of discomfort, the patch may be removed by gently peeling the tablet from the sides while washing with warm water. Do not use any instrument to remove the patch. children under 5 years, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients annatto, carbomer homopolymer type a, flavor, hydroxypropyl cellulose, potassium magnesium chloride hydrate, povidone K30, povidone K90, silicon dioxide, xylitol
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 associated with: canker sores mouth sores minor irritation of the mouth and 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 Canker Cover Menthol ANNATTO CARBOMER HOMOPOLYMER TYPE A HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM CHLORIDE POVIDONE K30 POVIDONE K90 SILICON DIOXIDE XYLITOL MENTHOL MENTHOL
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 DenTek CANKER COVER CANKER SORE PATCH 6 COUNT DenTek CANKER COVER CANKER SORE PATCH 6 COUNT
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.Other information store in a cool dry place.
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 sore mouth symptoms do not improve in 7 days irritation, pain or redness worsens swelling, rash or fever develops
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 800-4DENTEK (433-6835)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feedin g or taking prescription drugs, ask a health care professional 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 Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness worsens swelling, rash or fever develops If pregnant or breast-feedin g or taking prescription drugs, ask a health care professional before use. Keep out of reach of children. In case of accidental 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