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| Product NDC Code | 83592-802 | ||||
|---|---|---|---|---|---|
| Drug Name | Fraiche kids bubble gum mouthwash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 240698 | ||||
| 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 SODIUM FLUORIDE 0.05% (0.02% 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 Use once a day after brushing your teeth with a toothpaste Remove cap Hold bottle upright and squeeze. Fill to FILL LINE (10mL) Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out Do not swallow the rinse Do not eat or drink for 30 minutes after rinsing Instruct children under 12 years of age in good rinsing habits (to minimize swallowing) Supervise children as necessary until capable of using without supervision Children under 6 years of age : consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Cetylpyridinium chloride, dipotassium glycyrrhizinate, disodium phosphate, flavor, glycerin, poloxamer 407, polysorbate 20, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, stevia rebaudiana leaf/stem extract, water, xylitol.
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 Dental Caries Preventive
Spl product data elements
Usually a list of ingredients in a drug product.Fraiche Kids Bubble Gum Mouthwash SODIUM FLUORIDE CETYLPYRIDINIUM CHLORIDE GLYCYRRHIZINATE DIPOTASSIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS GLYCERIN POLOXAMER 407 POLYSORBATE 20 PROPYLENE GLYCOL SODIUM BENZOATE SODIUM PHOSPHATE SORBITOL STEVIA REBAUDIUNA LEAF WATER XYLITOL 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
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.
This product does not contain ethyl alcohol.
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 . If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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