Other
Drug Facts
Made By Dentists, Inc. Rebuilding Paste
FDA Label NDC 75065-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Made By Dentists, Inc. for the product Made By Dentists, Inc. Rebuilding (NDC 75065-019). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient:
Potassium Nitrate 5.0%
Sodium Fluoride 0.24%
Otc - Purpose
Purpose
Potassium Nitrate .... Desensitizer
Sodium Fluoride ....... Anticavity
Indications & Usage
Use: Aids in the prevention of cavities. Helps
Reduce painful sensitivity of teeth to cold,
heat, acids, sweets, or contact.
Warnings
Warnings:
Sensitive teeth may indicate a serious problem
that may need prompt care by a dentist. See
your dentist if the problem persists or worsens.
Do not use this product longer than 4 weeks
unless recommended by a dentist or doctor.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
Directions:
• Adults and children 12 years of age and older:
Apply at least a 1-inch strip of the product onto a
soft bristle toothbrush. Brush teeth thoroughly for
at least 1 minute twice a day, (morning and evening)
or as recommended by a dentist or doctor.
• Make sure to brush all sensitive areas of the teeth.
• Children under 12 years of age: Consult a dentist
or doctor.
Inactive Ingredient
Inactive Ingredients:
Cellulose Gum, Citric Acid, Cocamidopropyl
Betaine, Flavor, Hydrated Silica, Hydroxyapatite,
Potassium Sorbate, Sodium Bicarbonate, Sodium
Saccharin, Sodium Tripolyphosphate, Sorbitol,
Titanium Dioxide, Water, Xylitol
Otc - Questions
Questions? +1 (646) 980-6461
Rebuilding Toothpaste Product Labeling
Rebuilding Toothpaste
Made By Dentists ™
Fresh Mint Flavor
NET WT 4.2 Oz / 120g
MADE IN THE USA
@Copyright: 2022 Made By Dentists
439 S. Cedros Avenue, Suite 402.
Solana Beach, CA, 92075
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