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| Product NDC Code | 36800-213 | ||||
|---|---|---|---|---|---|
| Drug Name | Anticavity fluoride rinse |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 240698 | ||||
| Application Number | part355 | ||||
| Labeler Name | Topco Associates, 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 *This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash DISTRIBUTED BY: TOCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 (C) TOPCO VIJ717 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com QUALITY GUARANTEED This Top Care product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 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 now 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 necessay 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 Fluoride Rinse 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, MONOHYDRATE 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 COMPARE TO ACT* TopCare everyday ALCOHOL FREE Anticabity Fluoride Mouth Rinse MINT Helps prevent cavities Helps strengthen teeth Freshens breath IMPORTANT: Read direction for proper use. ADA Accepted American Dental Association Helps prevent cavities 18 FL OZ (1 PT 2 FL OZ) 532 mL image description
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, seek 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.SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-423-0139
Storage and handling
Information about safe storage and handling of the drug product.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