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| Product NDC Code | 59450-901 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 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 | 505G(a)(3) | ||||||||
| Labeler Name | Kroger | ||||||||
| 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 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 twice a day for 30 seconds then spit out; do not swallow {the rinse} children 6 years to under 12 years of age - supervise use children under 6 years of age - do not use 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% v/v), sorbitol, capryl/capramidopropyl betaine, flavor, benzoic acid, Stevia rebaudiana leaf extract, sodium benzoate
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.Mouth Rinse Eucalyptol, Menthol, Methyl salicylate, Thymol WATER ALCOHOL SORBITOL CAPRYL/CAPRAMIDOPROPYL BETAINE BENZOIC ACID STEVIA REBAUDIUNA LEAF SODIUM BENZOATE 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 Panel Display SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION simple truth Breath & Gum Cleanser ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH WITH ESSENTIAL OILS HERBAL MINT fights bad breath helps prevent plaque & gingivitis imrproves oral hygiene for refreshing oral care NO ARTIFICIAL SWEETNERS OR DYES NO POLYETHYLENE GLYCOL 33.8 FL OZ (1.05 QT) 1L 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.DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 For More Proudct Information, Scan UpcUsing Your Kroger App or Call 800-632-6900 No Animal TestingDSP-TN-21091 DSP-MO-20087Our Brands, Our Guarantee. Love It or Your Money Backwww.simpletruth.com
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.
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? Call roll free 1-800-632-6900
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 (59°to 86°F)
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