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Product NDC Code | 61284-0012 | ||||
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Drug Name | Truwell dentiwash |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 240698 | ||||
Application Number | M021 | ||||
Labeler Name | ECOWORLDPHARM CO.,LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.sodium fluoride
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.for dental use only
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.purified water, glycerin, xylitol, green tea extract, acetic acid, strawberry flavoring, sodium acetate, grapefruit seed extract, sodium benzoate, L-menthol, sodium saccharin, chitosan
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.Adults and children 6 years of age and older: use twoce a day after brishing your teeth with a toothpaste vigorously swish contents of one (1) 11mL packet between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision Children uder 6 years of age: consult a dentist or doctor
Purpose
Information about the drug product’s indications for use.aids in the prevention of dental cavities
Spl product data elements
Usually a list of ingredients in a drug product.Truwell Dentiwash sodium fluoride XYLITOL MALIC ACID WATER SODIUM FLUORIDE FLUORIDE ION
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
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 THE CHILDREN
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.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