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| Product NDC Code | 63615-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Cavity protection fresh mint anticavity mouthwash |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | MOUTHWASH | ||||||
| RxCUI drug identifier | 240698 | ||||||
| Application Number | M021 | ||||||
| Labeler Name | Oxyfresh Worldwide Inc | ||||||
| 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 0.05% Purpose Anticavity rinse
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 Shake well before using. Vigorously swish 1-2 capfuls for a minimum of 1 full minute. Refrain from rinsing, eating or drinking for 5 minutes.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INGREDIENTs Water (Aqua), Xylitol, Sodium Benzoate, Potassium Phosphate, Flavor*, Stabilized Chlorine Dioxide (Oxygene), Sodium Hydroxide, Citric Acid. *Contains Peppermint Essential Oil
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.Uses Helps protect against cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity rinse
Spl product data elements
Usually a list of ingredients in a drug product.Cavity Protection Fresh Mint Anticavity Mouthwash SODIUM FLUORIDE CHLORINE DIOXIDE WATER XYLITOL SODIUM BENZOATE POTASSIUM PHOSPHATE, UNSPECIFIED FORM OXYGEN SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE SODIUM FLUORIDE 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.Package Labeling:473ml Outer Package2
Package Labeling:3.8 L 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
Other information Store away from direct sunlight.
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 safety seal is torn or missing.
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 six years of age. Not to be used by children under six, unless recommended by a dentist or physician. If more than one ounce is accidentally swallowed, contact a physician or Poison Control Center right away.
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 For rinsing only. Do not swallow. Keep out of reach of children under six years of age. Not to be used by children under six, unless recommended by a dentist or physician. If more than one ounce is accidentally swallowed, contact a physician or Poison Control Center right away. Do not use if safety seal is torn or missing.
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