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| Product NDC Code | 44038-0686 | ||||
|---|---|---|---|---|---|
| Drug Name | Hello unicor sparkle |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M021 | ||||
| Labeler Name | Accupac LLC | ||||
| 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% (0.15% w/v fluoride ion)
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Hello Unicorn Sparkle
Drug Facts
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 thoroghly, preferably after each meal or at least twice a day, or as directed by a dentist of physician. children 2 to 6 years-use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). children under 2 years-ask a dentist of physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients sorbitol, purified water, hydrated silica, glycerin, xylitol, xanthan gum, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, stevia rebaudiana leaf extract, mica, titanium dioxide.
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 help protect against 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.Hello Unicor Sparkle Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION XYLITOL XANTHAN GUM MICA TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE WATER HYDRATED SILICA GLYCERIN SODIUM COCOYL GLUTAMATE SORBITOL STEVIA REBAUDIUNA LEAF
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.PRINCIPAL DISPLAY PANEL - 119 g Tube Carton naturally friendly hello unicorn sparkle fluoride toothpaste kids ages 2+ bubble gum natural flavor prevents cavities polishes + brightens strengthens enamel tastes magical never tested on unicorns no artificial sweeteners. no dyes. no SLS/sulfates. no brainer. NET WT 4.2 OZ (119g) 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 855-HI-HELLO (1-855-444-3556) Dist. by Hello Products LLC Montclair, NJ 07042
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 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