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| Product NDC Code | 41167-0978 | ||||||
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| Drug Name | Act restoring anticavity fluoride mint burst |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | MOUTHWASH | ||||||
| RxCUI drug identifier | 313029, 1044540 |
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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 0.02% (0.009% 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 a dults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above 10 mL mark 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 c hildren 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, sorbitol, poloxamer 407, propylene glycol, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-165)
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 Restoring Anticavity Fluoride Mint Burst Sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL POLOXAMER 407 PROPYLENE GLYCOL SODIUM PHOSPHATE POLYSORBATE 20 SACCHARIN SODIUM SUCRALOSE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS CETYLPYRIDINIUM CHLORIDE EDETATE CALCIUM DISODIUM ANHYDROUS SODIUM BENZOATE POTASSIUM SORBATE FD&C YELLOW NO. 5 FD&C GREEN NO. 3
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 #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L) #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L)
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 ® Restoring ™ Mint Burst Anticavity Fluoride Rinse Drug Facts
Other information contains FD&C yellow no. 5 (tartrazine) as a color additive 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.W arnings 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