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| Product NDC Code | 83013-308 | ||||
|---|---|---|---|---|---|
| Drug Name | Hismile strawberry flavor anticavity |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | part355 | ||||
| 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 0.24% (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 habits (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, Hydrated Silica, Xylitol, Glycerin, Disodium Phosphate, Flavor, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Caprylyl Glycol, Pentylene Glycol, Benzyl Alcohol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, D&C Red No.33.
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 STRAWBERRY FLAVOR anticavity Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA XYLITOL GLYCERIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM LAUROYL SARCOSINATE XANTHAN GUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POTASSIUM PYROPHOSPHATE CAPRYLYL GLYCOL PENTYLENE GLYCOL BENZYL ALCOHOL SUCRALOSE METHYL DIISOPROPYL PROPIONAMIDE SODIUM GLUCONATE ZINC LACTATE BENZOIC ACID D&C RED NO. 33
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.Packaging strawberry308
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.Drug Facts
Manufactured for: Hismile Pty Ltd, 225 Burleigh Connection Rd, Burleigh Waters, Queensland, Australia 4220. Formulated in Australia. Made in Thailand. www.hismileteeth.com © Hismile Pty Ltd, 2022 TRUSTED BY DENTISTS sugar-free cruelty-free no SLS & PEGs vegan Hismile uses the highest quality ingredients to provide a superior clean with oral health benefits. Paired with a refreshing burst of flavor, this toothpaste creates a unique smile care experience.
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
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? +1-302-440-3558 You may also report serious side effects to this phone number.
Storage and handling
Information about safe storage and handling of the drug product.Other information store in a cool, dry place.
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 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