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| Product NDC Code | 66923-201 | ||||
|---|---|---|---|---|---|
| Drug Name | Firefly strawberry natural fluoride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| Application Number | M021 | ||||
| Labeler Name | Ranir LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride 0.24%
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, preferable 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 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, xylitol, glycerin, flavor, xanthan gum, lauryl glucoside, cocamidopropyl betaine, sodium bicarbonate, stevia rebaudiana leaf extract
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 helps protect against cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Firefly Strawberry Natural Fluoride sodium fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA XYLITOL GLYCERIN XANTHAN GUM LAURYL GLUCOSIDE COCAMIDOPROPYL BETAINE SODIUM BICARBONATE STEVIA REBAUDIUNA LEAF
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.Package/Label Principal Display Panel Firefly® STRAWBERRY natural fluoride toothpaste 98% natural origin L.O.L. SURPRISE! ™ FIGHTS CAVITIES NO artificial flavors NO artificial colors ADA Accepted American Dental Association® NET WT 4.2 oz (119 g) firefly-strawberry-nlv-c
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 right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Toll Free: 1-866-373-7374
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 used for brushing 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