Label: MADE BY DENTISTS, INC. REBUILDING- potassium nitrate, sodium fluoride paste
- NDC Code(s): 75065-019-06
- Packager: Made By Dentists, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 30, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTIONS
- Rebuilding Toothpaste Product Labeling
-
INGREDIENTS AND APPEARANCE
MADE BY DENTISTS, INC. REBUILDING
potassium nitrate, sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75065-019 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75065-019-06 1 in 1 CARTON 01/24/2023 1 120 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/24/2023 Labeler - Made By Dentists, Inc. (117405870) Registrant - Made By Dentists, Inc. (117405870)
