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| Product NDC Code | 63404-0229 | ||||
|---|---|---|---|---|---|
| Drug Name | Sprinjene natural bubble gum |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 891775 | ||||
| Application Number | M021 | ||||
| Labeler Name | Health and Natural Beauty USA Corp | ||||
| Packages |
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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 Supervise children as necessary until capable of using without supervision. Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Deionized), Xylitol, Sorbitol, Hydrated Silica, Glycerin, Corn Zemea (1,3-Propanediol), Xanthan, Zinc Citrate, Sodium Lauryl Sulfoacetate, Flavor, Acacia Gum, Mica, potassium sorbate, Nigella Sativa Extract (Black seed Oil), Thyme (Thymus Vulgaris), Zingiber officinale (Ginger Oil), Punica granatum Seed Oil (Pomegranate), Commiphora myrrha (Myhrr oil), Rosemary (Rosmarinus Officinalis)
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 Helps in the prevention of 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.SprinJene Natural Bubble Gum Sodium Fluoride Sodium Fluoride Fluoride Ion WATER Xylitol Sorbitol Hydrated Silica Glycerin PROPANEDIOL Xanthan Gum Zinc Citrate Sodium Lauryl Sulfoacetate ACACIA Mica Potassium Sorbate NIGELLA SATIVA SEED OIL Thyme GINGER OIL POMEGRANATE SEED OIL MYRRH OIL ROSEMARY BUBBLE GUM
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 - 100 g Tube Carton SprinJene Natural ® CAVITY PROTECTION CHILDREN'S TOOTHPASTE with Black Seed Oil & Zinc BUBBLE GUM CAVITY PROTECTION FRESHENS BREATH HELPS DRY MOUTH NET WT 3.4 OZ (100g) PRINCIPAL DISPLAY PANEL - 100 g Tube Carton
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 and Dist. by: Health and Natural Beauty USA Corp, Piscataway, NJ 08854
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? Call 1-844-346-2872 www.sprinjene.com
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