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| Product NDC Code | 66923-111 | ||||
|---|---|---|---|---|---|
| Drug Name | Firefly anticavity fluoride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 240698 | ||||
| Application Number | part355 | ||||
| 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 0.05%
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 6 years of age and older: • use once a day after brushing your teeth with a toothpaste • 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, citric acid, D&C red #33, disodium EDTA, disodium phosphate, FD&C blue#1, flavor, PEG-40, hydrogenated castor oil, poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose, 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.Use aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity rinse
Spl product data elements
Usually a list of ingredients in a drug product.Firefly Anticavity Fluoride sodium fluoride SODIUM FLUORIDE FLUORIDE ION CETYLPYRIDINIUM CHLORIDE CITRIC ACID MONOHYDRATE D&C RED NO. 33 EDETATE DISODIUM ANHYDROUS FD&C BLUE NO. 1 POLYOXYL 40 HYDROGENATED CASTOR OIL POLOXAMER 407 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM PHOSPHATE SORBITOL SUCRALOSE XYLITOL
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.Principal Display Panel FIREFLY™ ANTICAVITY Fluoride Rinse Disney PIXAR TOY STORY BUBBLE BERRY™ Helps PREVENT CAVITIES ADA Accepted American Dental Association Helps prevent cavities Alcohol FREE IMPORTANT: Read directions for proper use. 16 FL OZ (473 mL) firefly-anticavity-fluoride-rinse-toy-story-front firefly-anticavity-fluoride-rinse-toy-story-back
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 • recommended storage temperature 59°-86°F(15°-30°C) • do not use if printed plastic neckband is broken or missing
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. 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