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| Product NDC Code | 37012-213 | ||||
|---|---|---|---|---|---|
| Drug Name | Anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 240698 | ||||
| Application Number | part355 | ||||
| Labeler Name | Shopko Stores Operating Co., LLC | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reactions Manufactured by Vi-Jon, Inc., One Swan Drive, Smyrna, TN 37167 for Shopko Stores Operating Co., LLC www.shopko.com for consumer questions call 1-888-593-0593 SHOPKO Satisfaction Guaranteed by refund or exchange
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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 pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 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 minimixe 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 water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5
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 rinse
Spl product data elements
Usually a list of ingredients in a drug product.Anticavity Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION water SORBITOL MENTHOL METHYL SALICYLATE CETYLPYRIDINIUM CHLORIDE SACCHARIN SODIUM poloxamer 407 POLYSORBATE 20 PROPYLENE GLYCOL SODIUM PHOSPHATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS EDETATE CALCIUM DISODIUM EDETATE DISODIUM ANHYDROUS SODIUM BENZOATE POTASSIUM SORBATE BENZYL ALCOHOL FD&C GREEN NO. 3 FD&C YELLOW NO. 5
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 SHOPKO COMPARE TO THE ACTIVE INGREDIENT OF ACT Anticavity Fluoride Rinse Mint Flavor Strong cavity protection Helps strengthen teeth Helps prevent cavities Freshens breath Alcohol Free IMPORTANT: read directions for proper use 18 FL OZ (532 mL) image description
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.Disclaimer This product is not manufactured or distributed by Chattem, Inc, distributor of Act Anticavity Fluoride Rinse
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, see professional assistance or contact a Poison Control Center immediately
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature
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 for this product
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