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Anticavity - Medication Information

Product NDC Code 41250-581
Drug Name

Anticavity

Type Brand
Active Ingredients
Sodium fluoride .2 mg/ml
Route ORAL
Dosage Form MOUTHWASH
RxCUI drug identifier 313029
Application Number M021
Labeler Name Meijer Distribution, Inc
Packages
Package NDC Code Description
41250-581-86 1000 ml in 1 bottle, plastic (41250-581-86)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient 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 Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) 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 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, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

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.
Anticavity Sodium fluoride WATER ALCOHOL SORBITOL POLOXAMER 407 PROPYLENE GLYCOL SODIUM BENZOATE SODIUM PHOSPHATE POLYSORBATE 20 SACCHARIN SODIUM CETYLPYRIDINIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS EDETATE CALCIUM DISODIUM ANHYDROUS FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION

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 41250-581-86 meijer Compare to Act ® Restoring Anticavity Fluoride Mouthwash Active Ingredient* RESTORING ANTICAVITY Fluoride Rinse Sodium Fluoride And Acidulated Phosphate Topical Solution RESTORES ENAMEL Refreshing Mint Helps strengthen teeth Helps remineralize soft spots Freshens breath IMPORTANT: Read directions for proper use 33.8 FL OZ (1L) 1.05 QT 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 ® Restoring Anticavity Fluoride Mouthwash Cool Mint. DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com OUR QUALITY GUARANTEE The Meijer Family WWW.MEIJER.COM/sATISFACTION

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
TEP 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 1-888-593-0593

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

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