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| Product NDC Code | 67933-0016 | ||||
|---|---|---|---|---|---|
| Drug Name | Percara kids bubble gum |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 240698 | ||||
| Application Number | M021 | ||||
| Labeler Name | LEC Custom Products, 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 Ingredients Sodium fluoride 0.05% (Fluoride ion-0.0226%)
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 Remove cap Use approximately one tablespoon and rinse vigorously 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 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 benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene plycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, 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.Uses aids the prevention of dental 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.PerCara Kids Bubble Gum Sodium fluoride BENZYL ALCOHOL EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL D&C RED NO. 33 SODIUM BENZOATE SODIUM PHOSPHATE SODIUM PHOSPHATE DIBASIC DIHYDRATE SACCHARIN SODIUM SORBITOL WATER 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.PERCARA™ ALCOHOL FREE CAVITY PROTECTION kids BUBBLE GUM FLUORIDE RINSE 18 FL OZ (532 ML) PERCARA - Kids BG Fluoride Rinse
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 at room temperature
Distributed by: LEC Custom Products, Inc, Missisauga, ON L5S 1B8 MADE IN CANADA
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. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
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 reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center 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