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| Product NDC Code | 52000-109 | ||||
|---|---|---|---|---|---|
| Drug Name | Universal sensitive anti-cavity fluoride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 1038841 | ||||
| Application Number | M022 | ||||
| Labeler Name | Universal Distribution Center LLC | ||||
| 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 Ingredients Potassium Nitrate 5% Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)
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 12 years of age and older apply at least a 1-inch strip of product onto soft bristle toothbrush brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1
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 builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact. aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE potassium nitrate and sodium fluoride SORBITOL WATER SILICON DIOXIDE SODIUM LAURYL SULFATE XANTHAN GUM SACCHARIN SODIUM SODIUM BENZOATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED TITANIUM DIOXIDE FD&C BLUE NO. 1 D&C YELLOW NO. 10 POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION
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 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE label
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.
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 If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.
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 and ask a dentist if the problem persists or worsens. Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.
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 if pain\ sensitivity still persists after 4 weeks of use, please visit your 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.Warning
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