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| Product NDC Code | 48878-3317 | ||||
|---|---|---|---|---|---|
| Drug Name | Periomed |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| Application Number | M021 | ||||
| Labeler Name | Solventum US LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Stannous fluoride 0.63% w/w (0.19% w/v flouride 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: do not use before mixing with water use immediately after preparing the rinse use as directed by a dental professional use once a day after brushing your teeth with a toothpaste or as directed by your dentist remove cap and seal and replace with pump rotate spout counter clockwise to extend depress pump until medicine comes to the tip of the pump put 1/8 oz. (approx. 2 pump strokes) of concentrated PerioMed Rinse into the provided mixing vial add water to 1 oz. line on mixing vial tightly snap on the cap and shake well vigorously swish 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 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 flavor, glycerin, methyl paraben, propyl paraben, sodium saccharin
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.Uses aids in the prevention of childhood dental decay helps prevent gingivitis helps control plaque bacteria builds increasing protection against painful tooth sensitivity
Purpose
Information about the drug product’s indications for use.Purpose anticavity, antigingivitis, antihypersensitivity, mouthrinse
Spl product data elements
Usually a list of ingredients in a drug product.PerioMed Stannous Fluoride Stannous Fluoride Fluoride Ion Glycerin Methylparaben Propylparaben Saccharin MINT PerioMed Stannous Fluoride Stannous Fluoride Fluoride Ion Glycerin Methylparaben Propylparaben Saccharin FRUIT
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 – Box Label (Mint – 283.5 g) NDC 48878-3315-0 Mint 3M ESPE PerioMed™ 0.63% Stannous Fluoride Concentrate Antimicrobial Oral Rinse Non-Alcohol Formula IMPORTANT: Read directions carefully before using. Contents: 1 Bottle NET WT. 10 oz (283.5g) Principal Display Panel – Box Label (Mint – 283.5 g)
Principal Display Panel – Box Label (Mint – 78 g) NDC 48878-3315-2 Mint 3M ESPE PerioMed™ 0.63% Stannous Fluoride Concentrate Antimicrobial Oral Rinse Non-Alcohol Formula IMPORTANT: Read directions carefully before using. Contents: 1 Bottle NET WT. 2.75 oz (78g) Principal Display Panel – Box Label (Mint – 78 g)
Principal Display Panel – Box Label (Tropical Fruit – 283.5 g) NDC 48878-3317-0 Tropical Fruit 3M ESPE PerioMed™ 0.63% Stannous Fluoride Concentrate Antimicrobial Oral Rinse Non-Alcohol Formula IMPORTANT: Read directions carefully before using. Contents: 1 Bottle NET WT. 10 oz (283.5g) Principal Display Panel – Box Label (Tropical Fruit – 283.5 g)
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.Other information For professional use only products containing stannous fluoride may produce surface staining of the teeth adequate toothbrushing may prevent these stains which are not harmful and may be removed by your dentist see your dentist regularly this product is not intended for home or unsupervised consumer use for your protection, do not use if seal under the cap is broken or missing
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? 1-800-634-2249
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.
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 When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist. Stop use and ask a doctor if sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care. 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.
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