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| Product NDC Code | 62839-1152 | ||||
|---|---|---|---|---|---|
| Drug Name | Ap-24 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 313029 | ||||
| Application Number | part355 | ||||
| Labeler Name | NSE Products, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Sodium Fluoride 0.02% (0.01% 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 once 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 (Aqua), Sorbitol, Glycerin, Poloxamer 338, AP-24, ® the patented ultra-emulsion of medical grade, high molecular weight Dimethicone and the surfactants, Poloxamer 338 and Poloxamer 407, helps to remove plaque and helps reduce plaque buildup. Poloxamer 407, Dimethicone, Sodium Phosphate, Phosphoric Acid, Disodium EDTA, Sodium Saccharin, Sodium Benzoate, Flavor (Aroma).
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.AP-24 Sodium Fluoride Sodium Fluoride Fluoride Ion Water Sorbitol Glycerin Poloxamer 338 Poloxamer 407 Dimethicone Sodium Phosphate Phosphoric Acid Edetate Disodium Anhydrous Saccharin Sodium Sodium Benzoate
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 - 500 ml Bottle Label AP24 ® Anti-Plaque Fluoride Mouthwash NU SKIN ® 500 ml e (16.9 Fl. Oz.) PRINCIPAL DISPLAY PANEL - 500 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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if saftey seal is broken.
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. 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? 1-888-742-7626
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.Warning Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if saftey seal is broken.
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