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| Product NDC Code | 76162-953 | ||||
|---|---|---|---|---|---|
| Drug Name | Antigingivitis/antiplaque |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 1251617 | ||||
| Application Number | M505G(a)(3) | ||||
| Labeler Name | TopCo Associates LLC | ||||
| 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 reaction DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO VIJA1123 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrands.com Scan here for more information or call 1-888-423-0139
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Cetylpyridinium Chloride 0.05%
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 when used after brushing, rinse mouth with water first 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, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6
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.Antigingivitis/Antiplaque Cetylpyridinium Chloride WATER ALCOHOL PROPYLENE GLYCOL POLOXAMER 407 SUCRALOSE BENZOIC ACID SODIUM BENZOATE CINNAMALDEHYDE FD&C BLUE NO. 1 FD&C YELLOW NO. 6 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 Panel Display COMPARE TO CREST® PRO-HEALTH® INTENSE CLEAN MINT MOUTHWASH* TopCare ® everyday Powerful Fresh Antigingivitis/Antiplaque Mouthwash FRESH MINT Kills 99% of many bad breath germs** Freshens your breath Helps prevent plaque and gingivitis IMPORTANT: Read directions for proper use. 1 L (1.5 QT) 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 & Disclaimer QUALITY GUARANTEED 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 ® Intense Clean Mint Mouthwash. **Kills at least 99% of many organisims commonly associated with bad breath in as little as 15 seconds.
Other information this rinse is not intended to replace brushing or flossing
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.Tamper Evident Statement SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-423-0139
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 gum 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
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