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| Product NDC Code | 36800-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Anticavity fluoride rinse |
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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 | Topco Associates LLC | ||||
| 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 ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion) Purpose Anticavity rinse
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 milliters (10 mL mark on 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 minimize swallowing) 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, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, 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.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 BENZYL ALCOHOL EDETATE CALCIUM DISODIUM CETYLPYRIDINIUM CHLORIDE EDETATE DISODIUM SODIUM ACID PYROPHOSPHATE POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL D&C RED NO. 33 SODIUM BENZOATE SODIUM PHOSPHATE SACCHARIN SODIUM SORBITOL WATER SODIUM FLUORIDE FLUORIDE ION Bubble Gum Flavor
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 TOP CARE Children's Alcohol Free Anticavity Fluoride Rinse Strong cavity protection Helps strengthen teeth Helps prevent cavities Freshens breath Bubble Gum Flavor COMPARE TO ACT active ingredient IMPORTANT: READ DIRECTIONS FOR PROPER USE SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION 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.*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride rinse. Distributed by: TOPCO ASSOCIATES LLC 7711 GROSS POINT ROAD, SKOKIE, IL 60077 QUESTIONS? 1-888-423-0139
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.
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.Warnings for this product 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.
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