Otc - Active Ingredient
DRUG FACTS
Active Ingredient
Sodium Fluoride 0.22%
Dr. Jen Superpaste Ortho Paste, Dentifrice
FDA Label NDC 84181-359
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 Ortho (NDC 84181-359). 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 twice a day with a pea size amount for two minutes. Spit out excess and do not rinse. Wait 30 minutes before eating or drinking, or as directed by a dentist or
doctor. Instruct children under 6
years of age in good brushing and spitting 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 Carboxy-
methylcellulose, Natural Flavor, Menthol,
Sodium Methyl Cocoyl Taurate, Stevia
Rebaudiana Leaf Extract, Citric Acid, Aloe
Barbadensis (Aloe Vera), Illicium verum (Anise)
Extract, Papaya Extract, Prunus Serotina (Black
Cherry) Extract, Glycyrrhiza Uralensis (Chinese
Licorice) Root Extract, Mentha Spicata
(Spearmint), Mentha Arvensis (Peppermint),
Vitamin D3, Vitamin k2, Calendula
Dr. Jen Superpaste Product Package Labeling
++++++++++++++++++++++++++++++++
DR.JEN
SP
Super
Paste
ORTHO
10% PREMIUM
NANO-HYDROXYAPATITE,
FLUORIDE & XYLITOL
TOOTHPASTE
___________
Cool Mint
___________
3.4 FL. OZ. | 100 ML
DRJENNATURAL.COM
Dr. Jen
St. Paul, MN 55118
res
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