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| Product NDC Code | 30142-576 | ||||
|---|---|---|---|---|---|
| Drug Name | Oral antivavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| Application Number | part355 | ||||
| Labeler Name | Kroger Co | ||||
| Packages |
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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 Reactions DISTRIBUTED BY THE KROGER CO., OHIO 452020 QUALITY GUARANTEE www.kroger.com
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 a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between 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, cetlpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, 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 SODIUM FLUORIDE FLUORIDE ION WATER GLYCERIN CETYLPYRIDINIUM CHLORIDE POLOXAMER 407 PHOSPHORIC ACID METHYLPARABEN SACCHARIN SODIUM PROPYLPARABEN PROPYLENE GLYCOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1
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 COMPARE TO the active ingredient of CREST PRO-HEALTH COMPLETE ANTICAVITY FLUORIDE RINSE See Back Label Kroger Refreshing Mint ALCOHOL-FREE FLUORIDE MOUTHWASH ANTICAVITY FLUORIDE RINSE IMPORTANT: read directions for proper use. Helps Prevent Cavities Helps Make Enamel Stronger Helps Clean the Entire Mouth Helps Kill Germs that Cause Bad Breath Helps Freshen Breath No Alcohol Burn SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION 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.Claims This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.
Disclaimer CREST IS A REGISTERED TRADEMARK OF THE PROCTER & GAMBLE COMPANY, CINCINNATI, OHIO 45202. THE PROCTER & GAMBLE COMPANY IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-632-6900
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.claims Kroger FROM OUR FAMILY TO YOURS Refreshing Mint ALCOHOL FREE FLUORIDE MOUTHWASH
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