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| Product NDC Code | 67777-181 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sodium monofluorophosphate |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | DENTAL | ||||||||||||
| Dosage Form | PASTE | ||||||||||||
| RxCUI drug identifier | 545626 | ||||||||||||
| Application Number | M021 | ||||||||||||
| Labeler Name | Dynarex Corporation | ||||||||||||
| 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 Monofluorophosphate 0.76%
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 and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. • Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established. • Children under 2 years: Ask a dentist or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Calcium Carbonate, Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Silicate, Sorbitol, Titanium Dioxide
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(s) 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.Sodium Monofluorophosphate White Toothpaste SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM CARBONATE SODIUM SILICATE SORBITOL HYDRATED SILICA SACCHARIN SODIUM SODIUM BENZOATE WATER PEPPERMINT OIL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE
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.Label 5910 White Toothpaste 5910_IN_MASTER
Label 5911 White Toothpaste 5911_IN_MASTER
Label 5912 White Toothpaste 5912_BX_MASTER
Label 5913 White Toothpaste 5913_BX_MASTER
Label 5914 White Toothpaste 4914_BX_MASTER
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 Keep out of reach of childen under 6 years of age
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store between 15°-35ºC (59º-95ºF)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-396-2739 Monday - Friday 9AM - 5PM EST
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 you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediatley. Keep out of reach of children Keep out of reach of childen 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