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Product NDC Code | 67777-175 | ||||||
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Drug Name | Morning fresh |
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Type | Brand | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | PASTE | ||||||
RxCUI drug identifier | 545626 | ||||||
Application Number | M021 | ||||||
Labeler Name | Dynarex Corporation | ||||||
Packages |
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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 brushing and rinsing until good habits are established. • Children under 2 years: Use as Directed by a dentist or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Calcium Carbonate, Carboxymethylcellulose Sodium, Flavor, Methylparaben, Polyethyene Glycol 400, Propylparaben, Saccharin Sodium, Silicon Sioxide, Sodium Benzoate, Sodium Lauryl Sulphate, Sodium Pyrophosphate, Sodium Silicate, Sorbitol, Titanium Dioxide, Water
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.Morning Fresh Sodium Fluoride SODIUM BENZOATE SORBITOL SACCHARIN SODIUM WATER CARBOXYMETHYLCELLULOSE SODIUM SODIUM LAURYL SULFATE SILICON DIOXIDE SODIUM SILICATE SODIUM PYROPHOSPHATE TITANIUM DIOXIDE METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLPARABEN CALCIUM CARBONATE SODIUM MONOFLUOROPHOSPHATE 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.Label 4872 Morning Fresh Toothpaste, with Fluoride 4872_BX_MASTER
Label 4873 Morning Fresh Toothpaste, With Fluoride 4873_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 under 6 years of age If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
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 15º - 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 • Do not swallow Keep out of reach of children under 6 years of age If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
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