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| Product NDC Code | 83592-803 | ||||
|---|---|---|---|---|---|
| Drug Name | Fraiche kids paste, bubble gum flavor |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M021 | ||||
| Labeler Name | True Marker Pharmaceuticals, 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 0.24% w/w Sodium Fluoride
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 For adults and children 2 years of age or older, apply a small peasized amount of FRAICHE Kids dental gel to your toothbrush. For best results, brush for 2 minutes, expectorate and avoid eating or drinking for 30 minutes after brushing. Use twice daily. Replace cap after use. For children under 2 years of age, consult a dentist or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Pure Water, Glycerol, Sorbitol, CMC-NA, Propylene Glycol, Silicon Dioxide, Titanium Dioxide, Xylitol, Phosphoric Acid, Flavoring, Sodium Saccharin, Ethyl P-hydroxybenzoate, Propyl P-hydroxybenzoate, Butyl P-hydroxybenzoate, Sodium-N-lauroyl Sarcosinate.
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 Aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anti-cavity
Spl product data elements
Usually a list of ingredients in a drug product.Fraiche Kids Paste, Bubble Gum Flavor SODIUM FLUORIDE WATER GLYCERIN SORBITOL CARBOXYMETHYLCELLULOSE SODIUM PROPYLENE GLYCOL SILICON DIOXIDE TITANIUM DIOXIDE XYLITOL PHOSPHORIC ACID SACCHARIN SODIUM ETHYLPARABEN POTASSIUM BUTYL SALICYLATE SODIUM LAUROYL SARCOSINATE PROPYLPARABEN 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.Product label image description image description
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 at controlled room temperature, 68-77°F (20-25°C). Do not use if safety seal is broke or missing.
Questions or Comments? Call 1-888-811-2634 www.truemarkerpharma.com
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. If more than the recommended amount of the paste used for brushing is accidentally swallowed, get medical help or contact the Poison Control Center right away. In case of an allergic reaction, stop use, rinse mouth with water and seek medical advice.
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