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| Product NDC Code | 83013-325 | ||||
|---|---|---|---|---|---|
| Drug Name | Hismile |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M021 | ||||
| Labeler Name | HISMILE PTY 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.Active ingredient Sodium Fluoride 0.243% (0.14 w/v fluoride ion)
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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habtis ( to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water Sorbitol Glycerin Hydrated Silica Xylitol Sodium Phosphate Xanthan Gum Sodium Lauroyl Sarcosinate Tetrapotassium Pyrophosphate 1,2-Hexanediol Cellulose Gum Sucralose Lauryl Glucoside Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate Iron Oxides
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 Aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.HISMILE Sodium Fluoride FERROUS OXIDE XYLITOL HYDRATED SILICA SODIUM LAUROYL SARCOSINATE GLYCERIN 1,2-HEXANEDIOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM WATER SODIUM FLUORIDE FLUORIDE ION SORBITOL SODIUM PHOSPHATE XANTHAN GUM POTASSIUM PYROPHOSPHATE SUCRALOSE LAURYL GLUCOSIDE SODIUM GLUCONATE ZINC LACTATE METHYL DIISOPROPYL PROPIONAMIDE
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 label 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 brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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.When using this product Do not swallow Do not use in eye area
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 Warnings When using this product Do not swallow Do not use in eye area Keep out of reach of children under 6 years of age If more than used for brushing 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