Label: MADE BY DENTISTS, INC. TOTAL CARE- sodium fluoride paste
- NDC Code(s): 75065-018-06
- Packager: Made By Dentists, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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
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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 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
- QUESTIONS
- Whitening Toothpaste Product Labeling
-
INGREDIENTS AND APPEARANCE
MADE BY DENTISTS, INC. TOTAL CARE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75065-018 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75065-018-06 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 final part355 01/24/2023 Labeler - Made By Dentists, Inc. (117405870) Registrant - Made By Dentists, Inc. (117405870)
