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Anticavity fluoride rinse - Medication Information

Product NDC Code 55319-163
Drug Name

Anticavity fluoride rinse

Type Brand
Active Ingredients
Sodium fluoride .1 mg/ml
Route ORAL
Dosage Form MOUTHWASH
RxCUI drug identifier 313029
Application Number M021
Labeler Name Midwood Brands, Inc
Packages
Package NDC Code Description
55319-163-86 1000 ml in 1 bottle, plastic (55319-163-86)
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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 Reaction DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA MADE IN THE US WITH US AND FOREIGN COMPONENTS. NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or Exchange. DSP-TN-21091 DSP-MO-20087

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Sodium fluoride 0.02% (0.01% 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 12 years of age and older: use twice daily after brushing your teeth with 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 12 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 (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, 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 Fluoride Rinse SODIUM FLUORIDE WATER ALCOHOL SORBITOL POLOXAMER 407 EUCALYPTOL METHYL SALICYLATE MENTHOL PHOSPHORIC ACID SACCHARIN SODIUM THYMOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SUCRALOSE FD&C RED NO. 40 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 Sealed with printed neckband for your protection. Do not use if band around cap is broken or missing. FAMILY WELLNESS ™ COMPARE TO LISTERINE ® TOTAL CARE FRECH MINT ANTICAVITY MOUTHWASH MINT ANTICAVITY FLUORIDE RINSE Sodium Fluoride and Acidulated Phosphate Topical Solution MINT FLAVOR ANTICAVITY FLUORIDE MOUTHWASH Multiple benefits in one Helps prevent cavities and restore enamel Helps strengthen teeth 1 L (1.05 QT) 33.8 FL OZ 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 controlled room temperature 20⁰-25⁰ C (68⁰ - 77⁰F) cold weather may temporarily cloud this product Disclaimer This product is not manufacturd or distributed by Johnson & Johnson Corporation, distributerof Listerine ® Total Care Fresh Mint Anticavity Mouthwash.

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.

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