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| Product NDC Code | 50804-299 | ||||
|---|---|---|---|---|---|
| Drug Name | Antiseptic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 1100924 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Perrigo Direct, Inc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Cetylpyridinium chloride 0.07% Purpose Antigingivitis, Antiplaque
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 & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow 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 water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, 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 control plaque that leads to 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.Antiseptic CETYLPYRIDINIUM CHLORIDE WATER GLYCERIN POLOXAMER 188 SACCHARIN SODIUM PROPYLENE GLYCOL SODIUM BENZOATE SUCRALOSE BENZOIC ACID FD&C BLUE NO. 1 CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM
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 GOODSENSE Alcohol Free Antiseptic Oral Rinse Antigingivitis/Antiplaque Mint Flavor Kills 99% of Germs for a healthier Mouth** Helps prevent Plaque Helps prevent gingivitis Helps keep teeth feeling clean Freshens Breath No burn of alcohol Compare to active ingredients of Crest Pro-Health Rinse* 1 LITER (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.claims GOODSENSE Alcohol Free Antiseptic Oral Rinse SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence. This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint **Killed at least 99% of representative plaque organisms commonly associated with gingivitis in as little as 15 seconds Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269 www.PerrigoDirect.com 1-888-593-0593 GoodSense is a registered trademark of L. Perrigo Company.
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 under 6 years of age. 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
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 dentist if gingivitis, bleeding or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
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 Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. 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