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| Product NDC Code | 54473-300 | ||||
|---|---|---|---|---|---|
| Drug Name | Koala pals berrylicious |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M022 | ||||
| Labeler Name | Melaleuca, 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 0.24% (fluoride ion 0.15% w/v)
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 older: 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: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years of age: ask a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, citric acid, flavor, glycerin, hydrated silica, natural lemon and orange flavor extracts, potassium sorbate, sodium benzoate, sodium bicarbonate, sodium lauroyl sarcosinate, sorbitol, water, xanthan gum, xylitol
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 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.koala pals berrylicious Sodium Fluoride ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM GLYCERIN HYDRATED SILICA POTASSIUM SORBATE SODIUM BENZOATE SODIUM BICARBONATE SODIUM LAUROYL SARCOSINATE SORBITOL WATER XANTHAN GUM XYLITOL 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.image of label
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.Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a 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
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