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Anticavity - Medication Information

Product NDC Code 79903-033
Drug Name

Anticavity

Type Brand
Active Ingredients
Sodium fluoride .5 mg/ml
Route ORAL
Dosage Form RINSE
RxCUI drug identifier 240698
Application Number part355
Labeler Name Wal-Mart
Packages
Package NDC Code Description
79903-033-44 532 ml in 1 bottle, plastic (79903-033-44)
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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 and older: use once a day after brushing your teeth with toothpaste 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 unitl 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, green 3, poloxamer 407, polysorbate 80, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, 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 BENZYL ALCOHOL EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE EDETATE DISODIUM ANHYDROUS SODIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C GREEN NO. 3 POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL SODIUM BENZOATE SODIUM PHOSPHATE SORBITOL SUCRALOSE WATER 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 NDC 79903-033-44 Equate Compare to Act Kids Anticavity Fluoride Rinse Wild Watermelon* Kids Anticavity Fluoride Rinse Alcohol-free Paraben-free Sugar-free Watermelon Flavor IMPORTANT: Read directions for proper use 18 FL OZ (1 PT 2 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.
Other information store at room temperature Sealed with printed neckband for your protection Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915 *This product is not manufactured or distributed by Chattem, Inc., distributor of Act Kids Anticavity Fluoride Rinse Wild Watermelon. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 Wal-Mart Stores, Inc. 201.000/201AA

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 accidentall swallowed, seek professional assistance or contact a Poison Control Center immediately.

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

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