Otc - Active Ingredient
DRUG FACTS
Active Ingredient
Sodium Fluoride 0.22%
Dr. Jen Superpaste Nano-hydroxyapatite Paste, Dentifrice
FDA Label NDC 84181-735
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr Jen Natural, Llc for the product Dr. Jen Superpaste Nano-hydroxyapatite (NDC 84181-735). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, dr. jen superpaste product package labeling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
Sodium Fluoride - Anticavity
Indications & Usage
Use: Aids in the prevention of dental cavities
Warnings
Warnings:
If more than used for brushing is
accidentally swallowed, get
medical help or contact a Poison
Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
under 6 years of age.
Dosage & Administration
Directions: Adults and children
2 years of age and older: Brush
teeth thoroughly, preferably after
each meal or at least twice a day,
or 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
Inactive Ingredients: Water,
Glycerin, Hydrated Silica, Xylitol,
Nano-Hydroxyapatite, Calcium
Carbonate, Sodium Methyl Cocoyl
Taurate, Sodium Carboxymethyl-
cellulose, Natural Strawberry Flavor,
Stevia Rebaudiana Leaf Extract, Citric
Acid, Illicium Verum (Anise) Fruit
Extract, Carica Papaya Extract, Prunus
Serotina (Black Cherry) Bark Extract,
Glycyrrhiza Uralensis (Chinese Licorice)
Root Extract
Dr. Jen Superpaste Product Package Labeling
Dr. Jen
Super Paste
TRIPLE CAVITY
PROTECTION
10% NANO-HYDROXYAPATITE,
FLUORIDE & XYLITOL
TOOTHPASTE
Strawberry
3.4 FL. OZ. | 100 ML
DrJenNatural.com
Dr. Jen
St. Paul, MN 55118
res
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