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Oral antivavity - Medication Information

Product NDC Code 72288-576
Drug Name

Oral antivavity

Type Brand
Active Ingredients
Sodium fluoride 10.41 mg/ml
Route ORAL
Dosage Form MOUTHWASH
Application Number M021
Labeler Name Amazon.Com Services LLC
Packages
Package NDC Code Description
72288-576-86 1000 ml in 1 bottle, plastic (72288-576-86)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Sodium fluoride 0.0219% (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 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse bwtween your teeth for 1 minute 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 witout 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, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, 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.
Oral Antivavity Sodium fluoride WATER GLYCERIN CETYLPYRIDINIUM CHLORIDE SACCHARIN SODIUM PHOSPHORIC ACID SODIUM BENZOATE SUCRALOSE POLOXAMER 407 BENZOIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PROPYLENE GLYCOL 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 amazon basics anticavity fluoride mouthwash Alcohol Free Refreshing Mint Flavor IMPORTANT: READ DIRECTIONS FOR PROPER USE 33.8 fl oz (1 L) 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 rinse may cause temporary staining to the surface of teeth. This is not harmful, add adequate brushing may prevent its occurrence. Sealed with printed neckband for your protection. DISTRIBUTED BY: Amazon.com, Services, Inc Seattle, WA 98109 1-877-485-0385 2021 Amazon.com, Inc. or its afiliated. All rights reserved. Solimo and all related logos are are trademarks of Amazon.com, Inc or its affiliates. SEALED WITH PRINTED NECKBAND FOR YOUR PORTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

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