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| Product NDC Code | 84045-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Zohar fluoride anti cavity coolmint flavour |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | M021 | ||||
| Labeler Name | ZOHAR KOSHER LIMITED | ||||
| 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 Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion) Purpose Anticavity
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 Do not swallow Supervise children as necessary until capable of using without supervision. Adults and children 2 years of age 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 years Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years Ask a dentist or physician
| Adults and children 2 years of age 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 years | Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) |
| Children under 2 years | Ask a dentist or physician |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Calcium Carbonate, Water, Glycerin, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin.
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
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Zohar Fluoride Anti Cavity Coolmint Flavour SODIUM MONOFLUOROPHOSPHATE CALCIUM CARBONATE WATER GLYCERIN HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM BENZOATE SACCHARIN SODIUM SODIUM MONOFLUOROPHOSPHATE 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.Label Label.jpg Inner Label.jpg
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
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. If more than used for brushing is accidentally swallowed, get medical help 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 Do not use if irritation occurs and persists. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help 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