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Drug Facts
Made By Dentists, Inc. Whitening Paste
FDA Label NDC 75065-017
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. Whitening (NDC 75065-017). 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:
Sodium Fluoride 0.24%
Otc - Purpose
Purpose Anticavity
Indications & Usage
Use: Aids in the prevention of cavities.
Warnings
Warnings:
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 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 swall-
owing), and only use a pea size amount
• 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:
Sorbitol, Water, Hydrated Silica, Xylitol, Sodium
Tripolyphosphate, Flavor, Cocamidopropyl Betaine,
Cellulose Gum, Titanium Dioxide, Potassium
Sorbate, Sodium Saccharin, Citric Acid, Hydrogen
Peroxide, Sodium Bicarbonate
Otc - Questions
Questions? +1 (646) 980-6461
Whitening Toothpaste Product Labeling
Whitening Toothpaste
Made By Dentists™
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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