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| Product NDC Code | 83566-201 | ||||||||||||||||||||||||||||||||
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| Drug Name | Mouth rinse |
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| Type | Brand | ||||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||||||||||||||||||||
| Application Number | M021 | ||||||||||||||||||||||||||||||||
| Labeler Name | Guangdong Aimu Biological Technology Co., Ltd | ||||||||||||||||||||||||||||||||
| 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.MENTHOLUM 0.02% MENTHONE GLYCERIN ACETAL 0.005%
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.Applicable population: Children over 6 years oldStorage conditions: Store in a cool and dry place,avoiding direct sunlight
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.WATER CETYLPYRIDINIUM CHLORIDE POLOXAMER 407 POTASSIUM SORBATE SUCRALOSE SODIUM BENZOATE SODIUM SACCHARIN CITRIC ACID CI42090
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.Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.
Purpose
Information about the drug product’s indications for use.Clean the oral cavity and prevent oral diseases
Spl product data elements
Usually a list of ingredients in a drug product.Mouth Rinse MENTHOLUM 0.02% MENTHONE GLYCERIN ACETAL 0.005% ANHYDROUS CITRIC ACID WATER MENTHOL MENTHOL MENTHONE 1,2-GLYCEROL KETAL, (+/-)- MENTHONE 1,2-GLYCEROL KETAL, (+/-)- CETYLPYRIDINIUM CHLORIDE POLOXAMER 407 POTASSIUM SORBATE SUCRALOSE SODIUM BENZOATE SACCHARIN DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM
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.label label2 label3 label4 label5
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.MOUTH RINSE
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 under the age of six, and do not use if there is a wound in the mouth.
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.
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.If adverse reactions occur during use, please seek medical assistance immediately.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.
Storage and handling
Information about safe storage and handling of the drug product.Storage conditions: Store in a cool and dry place,avoiding direct sunlight
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.Do not swallow, please keep out of reach of children. For use only by people aged six and above.
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