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| Product NDC Code | 66923-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Reach anti plaque |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 1599135 | ||||
| Application Number | part356 | ||||
| Labeler Name | Ranir 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 Cetylpyridinium chloride 0.075%
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 • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use Adults and children 6 years of age and older: • vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow rinse. Children 6 years to under 12 years of age: supervise use Children under 6 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients purified water, glycerin, propylene glycol, poloxamer 407, PEG-40 hydrogenated castor oil, flavor, sucralose, disodium phosphate, citric acid, D&C red #33, FD&C 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 helps prevent and reduce plaque and gingivitis
Purpose
Information about the drug product’s indications for use.Purpose Antigingivitis/antiplaque
Spl product data elements
Usually a list of ingredients in a drug product.Reach Anti Plaque cetylpyridinium chloride CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM WATER GLYCERIN PROPYLENE GLYCOL POLOXAMER 407 POLYOXYL 40 HYDROGENATED CASTOR OIL SUCRALOSE CITRIC ACID MONOHYDRATE D&C RED NO. 33 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.Package/Label Principal Display Panel REACH® ESSENTIALS™ ANTI-PLAQUE Antigingivitis/Antiplaque Oral Rinse 6 IN 1 BENEFITS - Kills Germs - Freshens Breath - Clean Mouth - Reduces Plaque - Fights Gingivitis - Alcohol-Free REFRESHING MINT 13.5 FL OZ (400 mL) reach-antiplaque-front reach-anti-plaque-back
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a dentist if symptoms persist or condition worsens after regular use.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use this product if gums are irritated or bleeding unless directed to do so by a doctor or dentist.
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 • this rinse is not intended to replace brushing or flossing • store at room temperature 59-86°F (15-30°C) • cold weather may temporarily cloud product, shake well if this occurs • do not use if printed safety seal 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? 1-866-373-7374 or [email protected]
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 Do not use this product if gums are irritated or bleeding unless directed to do so by a doctor or dentist. Ask a dentist if symptoms persist or condition worsens after regular use. 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