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| Product NDC Code | 71927-006 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Mouthwash |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1043619 | ||||||||
| Application Number | part356 | ||||||||
| Labeler Name | Orazen Inc | ||||||||
| 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 adult and children 12 years of age and older vigorously swish 20 millliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse. children 6 to 20 years of age supervise use children uner 6 years of age do not use
| adult and children 12 years of age and older | vigorously swish 20 millliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse. |
| children 6 to 20 years of age | supervise use |
| children uner 6 years of age | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alcohol (21.6%), benzoic acid, flavor, green 3, poloxamer 407, sodium benzoate, sodium saccharin, sorbitol, water
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.Uses Helps reduce plaque that leads to gingivitis bleeding gums
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.Mouthwash Menthol, Methyl salicylate, Thymol METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL ALCOHOL BENZOIC ACID EUCALYPTOL EUCALYPTOL FD&C GREEN NO. 3 POLOXAMER 407 SODIUM BENZOATE SACCHARIN SODIUM SACCHARIN SORBITOL WATER MENTHOL MENTHOL
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.image of bottle label
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 immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information not intended to replace brushing or flossing store at room temperature (59-77F) cold weather may cloud this product, but will not affect its antiseptic properties.
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 Stop use and see your dentist immediately 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 increasing space between the teeth These may be signs or symptoms of periodontitis, a serious form of gum disease.
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