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| Product NDC Code | 39892-0603 | ||||
|---|---|---|---|---|---|
| Drug Name | Medichoice premium anticavity fluoride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 891775 | ||||
| Application Number | M021 | ||||
| Labeler Name | Owens & Minor | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Sodium Fluoride - 0.243% (0.15% 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 2 years of age and olden Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age should use only a pea-sized amount in order to minimize swallowing. Supervise children and help them create good brushing and rinsing habits until capable of using without supervision. Children under 2 years of age: Consult a dentist or a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS sorbitol, silica, water, glycerin, polythelene glycol 1500, sodium lauryl sulfate, flavor, titanium dioxide, cellulose gum, carrageenan, trisodium orthophosphate, sodium saccharin, sodium benzoate, tetrasodium pyrophosphate, methylparaben, propylparaben, FD & C blue #1 Made in India, Distributed by Owens & Minor, 9120 Lockwood Boulevard, Mechanicsville, VA 23116 C.No. DNH/COS/DNH/52Exp. Date & Lot No. on Crimp Rev. 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.MediChoice Premium Anticavity Fluoride SODIUM FLUORIDE SORBITOL SILICON DIOXIDE WATER GLYCERIN POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE SACCHARIN SODIUM SODIUM BENZOATE SODIUM PYROPHOSPHATE METHYLPARABEN PROPYLPARABEN FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION Cool 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.MediChoice Premium Anticavity Fluoride Toothpaste 24g (39892-0603-2) Medichoice0603
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.MediChoice Premium Anticavity Fluoride Toothpaste 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.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children under 6 years of age.
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 If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children under 6 years of age.
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