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Product NDC Code | 72247-107 | ||||||
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Drug Name | Curodont protect |
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Type | Brand | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | PASTE, DENTIFRICE | ||||||
RxCUI drug identifier | 416784 | ||||||
Application Number | part355 | ||||||
Labeler Name | CREDENTIS AG | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS STANNOUS FLUORIDE 0.454% (0.14% 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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 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, Hydrated Silica, Sodium Tripolyphosphate, Sodium Gluconate, Xylitol, Cellulose Gum, Oligopeptide-104, Sodium Hydroxide, Phosphoric Acid.
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 AIDS IN THE PREVENTION OF DENTAL CAVITIES AND BUILDS INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH.
Purpose
Information about the drug product’s indications for use.PURPOSE ANTICAVITY AND ANTISENSITIVITY
Spl product data elements
Usually a list of ingredients in a drug product.CURODONT PROTECT STANNOUS FLUORIDE SORBITOL SODIUM HYDROXIDE WATER HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE SODIUM GLUCONATE OLIGOPEPTIDE 104 XYLITOL STANNOUS FLUORIDE FLUORIDE ION CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED PHOSPHORIC ACID
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.PDP DF
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 MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, 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 This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by 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.WARNINGS Stop use and ask a doctor if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use.
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