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Product NDC Code | 82913-002 | ||||
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Drug Name | Autobrush strawberry |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | LIQUID | ||||
Application Number | part355 | ||||
Labeler Name | Lander Enterprises, 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, preferably after each meal or at least twice per day, or as directed by a dentist or physician. ● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). ● Shake before use. ● Squirt two times into your mouth and start brushing. ● Supervise children as necessary until capable of using without supervision. ● 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 Aqua, Glycerin, Sorbitol, Poloxamer, Xylitol, Natural Strawberry Flavor, Nano Silver, Potassium Sorbate, Stevioside, Citric Acid, Calcium Citrate
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 Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.AutoBrush strawberry Sodium Fluoride WATER GLYCERIN SORBITOL POLOXAMER 407 XYLITOL SILVER POTASSIUM SORBATE STEVIOSIDE CITRIC ACID MONOHYDRATE CALCIUM CITRATE 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.● Questions? ● Email Support: [email protected] ● Phone Support: 1-888-468-7404
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 Central 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