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| Product NDC Code | 51009-840 | ||||
|---|---|---|---|---|---|
| Drug Name | Toms childrens anticavity mouthwash silly strawberry |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 831877 | ||||
| Application Number | M021 | ||||
| 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 (in each 10mL) Sodium fluoride 0.04% (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 Adults and children 6 years of age and older: use twice 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 water, glycerin, Aloe barbadensis leaf juice organic , xylitol, sodium phosphate, propanediol, benzoic acid, natural flavor, phosphoric acid, menthol, Fragaria ananassa (Strawberry) fruit juice, Ananas sativus (Pineapple) fruit juice, Citrus aurantium dulcis (Orange) juice, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Rebaudioside A
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
Spl product data elements
Usually a list of ingredients in a drug product.Toms Childrens Anticavity Mouthwash Silly Strawberry sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER GLYCERIN PROPANEDIOL XYLITOL SODIUM PHOSPHATE BENZOIC ACID ALOE VERA LEAF LEVOMENTHOL PHOSPHORIC ACID STRAWBERRY JUICE PINEAPPLE JUICE ORANGE JUICE LEMON JUICE MANGO JUICE REBAUDIOSIDE A
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 - 473 mL Bottle Label SINCE 1970 Tom's OF MAINE ® alcohol-free | natural children's anticavity fluoride rinse cavity protection for a healthy smile tastes great dye free ADA Accepted American Dental Association® silly strawberry 16 FL OZ (473 mL) with real fruit juice! P9937074 IMPORTANT: Read directions for proper use PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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
Dist. by TOM'S OF MAINE, INC., KENNEBUNK, ME 04043 U.S.A.
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
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 (1-800-367-8667)
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