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| Product NDC Code | 36800-072 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Antiseptic mouth rinse |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | MOUTHWASH | ||||||||
| RxCUI drug identifier | 1043619 | ||||||||
| Application Number | M017 | ||||||||
| 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 *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributer of FreshBurst Listerine Antiseptic Mouthwash. DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com The Top Care product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%
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 12 years of age and older - vigorously swish 20 mL (2.3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no. 3
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 Mouth Rinse Eucalyptol, Menthol, Methyol salicylate, Thymol WATER ALCOHOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM CITRATE D&C YELLOW NO. 10 FD&C GREEN NO. 3 EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL
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 LISTERINE* TopCare everyday Antiseptic Mouthwash ANTIGINGIVITIS/ANTIPLAQUE SPRING MINT For better oral hygiene & fresher breath Kills germs that cause bad breath, plaque & the gum disease gingivitis ADA Accepted American Dental Association Helps reduce plaque Helps reduce gingivitis 33.8 FL OZ (1 QT 1.8 FL OZ) 1 L image description
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 if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. these may be signs of periodontitis, a serious form of gum disease.
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.SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION Active ingredients Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰F)
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 Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. these may be signs of periodontitis, a serious form of gum disease. Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks. 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