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| Product NDC Code | 84132-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Decure |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | M021 | ||||
| Labeler Name | Scope medical devices private limited | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Sodium Monofluorophosphate 0.76%
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 2 years and older. Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician Children under 6 yrs. To minimize swallowing use a pea - sized amount and supervise brushing until good habits are established. Children under 2 yrs. Ask a dentist or physician.
| Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician | |
| Children under 6 yrs. | To minimize swallowing use a pea - sized amount and supervise brushing until good habits are established. |
| Children under 2 yrs. | Ask a dentist or physician. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Calcium Carbonate, Water, Sorbitol, Silica, Sodium Lauryl Sulphate, Flavor, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate
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: Regular brushing with Fluoride toothpaste helps protect teeth roots against cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity (Total Fluoride Content - 1000 ppm Approx.)
Spl product data elements
Usually a list of ingredients in a drug product.DeCure Sodium Monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM CARBONATE WATER SORBITOL SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM SILICATE SODIUM PYROPHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED XANTHAN GUM BENZYL ALCOHOL SACCHARIN SODIUM SODIUM BENZOATE
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.Packaging ScopeMedical-100
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
With Fluoride Anticavity Protection Manufactured For: Scope Medical Devices Pvt. Ltd. 11/10, Mandhour Industrial Area, Ambala -134003, India Factory Neutral Code DNH/COS/DNH/52 Ref # :330139 Made in India Exp. Date & Batch No. on crimp.
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 under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
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: Keep out of reach of children under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
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