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Sprinjene fresh boost - Medication Information

Product NDC Code 63404-0910
Drug Name

Sprinjene fresh boost

Type Brand
Active Ingredients
Sodium fluoride 1.5 mg/g
Route DENTAL
Dosage Form GEL, DENTIFRICE
RxCUI drug identifier 891775
Application Number part355
Labeler Name Health and Natural Beauty USA Corp
Packages
Package NDC Code Description
63404-0910-1 1 tube in 1 carton (63404-0910-1) / 130 g in 1 tube
63404-0910-2 1 tube in 1 carton (63404-0910-2) / 42 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Sodium Fluoride 0.243% (0.15% 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 under 2 to 6 years instruct in good brushing and rinsing habbits (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, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, zinc citrate, black seed oil, xanthan, sodium saccharin, mica, FD&C Blue No. 1, FD&C Yellow No. 5

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 caries

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 Fresh Boost Sodium Fluoride Sodium Fluoride Fluoride Ion Water Hydrated Silica Glycerin Sorbitol Sodium Lauryl Sulfate CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED Zinc Citrate Guizotia Abyssinica Seed Oil Sodium Pyrophosphate Xanthan Gum Saccharin Sodium Mica FD&C Blue No. 1 FD&C Yellow No. 5 Minty

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 - 130 g Tube Carton NEW SprinJene ™ Fluoride Toothpaste Bursting with the unique benefits of Black Seed Oil CERTIFIED VEGAN VEGAN.ORG Fresh Boost Gel NET WT 4.6 OZ (130 g) Principal Display Panel - 130 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 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 toll free 1-844-3-462872 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