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| Product NDC Code | 51009-149 | ||||
|---|---|---|---|---|---|
| Drug Name | Simply white sweet mint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | part355 | ||||
| Labeler Name | Tom's of Maine, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride 0.24% (0.15% w/v fluoride ion) Purpose Anticavity
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 a day, or as directed by a dentist or physician. children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician
| adults and children 2 years of age and older: | brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. |
| children 2 to 6 years | use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) |
| children under 2 years | ask a dentist or physician |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients hydrated silica, water, sorbitol, glycerin, xylitol, sodium lauryl sulfate, natural flavors, xanthan gum, Chondrus crispus (carrageenan).
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
Spl product data elements
Usually a list of ingredients in a drug product.Simply White Sweet Mint Sodium fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER SILICON DIOXIDE GLYCERIN XYLITOL SODIUM LAURYL SULFATE MENTHOL, UNSPECIFIED FORM XANTHAN GUM PEPPERMINT OIL CARRAGEENAN ANISE VANILLIN CLOVE OIL ZINGERONE PIPERONAL Sweet Mint
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 - 133.2g Tube Carton new! SINCE 1970 Tom's OF MAINE ™ natural SIMPLY WHITE ® whitening | cavity protection | fresh breath fluoride toothpaste sweet mint gel NET WT 133.2g (4.7 OZ) PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton
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.Drug Facts
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 the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-FOR-TOMS M-F 8:30 a.m.-5 p.m. ET
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 the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).
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