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| Product NDC Code | 41167-0945 | ||||
|---|---|---|---|---|---|
| Drug Name | Act anticavity fluoride kids groovy grape |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 240698, 656809 |
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| Application Number | M021 | ||||
| Labeler Name | Chattem, 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 i ngredient Sodium fluoride 0.05% (0.02% 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 ■ remove cap ■ hold bottle upright and squeeze. Fill to FILL LINE. ■ pour out. Only the correct 10 milliliters dose will pour out. ■ 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 benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, 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 ■ 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.ACT Anticavity Fluoride Kids Groovy Grape Sodium fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, DIBASIC, ANHYDROUS BENZYL ALCOHOL FD&C BLUE NO. 1 EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE POLOXAMER 407 POLYSORBATE 20 POTASSIUM SORBATE PROPYLENE GLYCOL D&C RED NO. 33 SODIUM BENZOATE SODIUM PHOSPHATE SORBITOL SUCRALOSE WATER
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 ACT Kids ANTICAVITY FLUORIDE RINSE GROOVY GRAPE 16.9 fl oz (500 mL) ACT Kids ANTICAVITY FLUORIDE RINSE GROOVY GRAPE 16.9 fl oz (500 mL)
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.ACT Anticavity Kids Rinse Groovy Grape 0.05% Drug Facts
Other information ■ do not use if safety seal is broken 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. If more than used for rinsing 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 Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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