Label: ORTHOCARE- sodium fluoride paste, dentifrice
- NDC Code(s): 73051-0754-1
- Packager: Orthosciences, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 20, 2023
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- Official Label (Printer Friendly)
- Inactive Ingredient
- Purpose
- Use
- Warnings
- Keep out of reach of children under 6 years of age.
- Other Information:
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Directions
- Adults and children 2 years of age and older: Use a pea sized amount and 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 swallowing). Supervise children's brushing until good habits are established.
- Children under 2 years: Consult a dentist or doctor.
- Inactive Ingredients
- Questions?
- Principal Display
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INGREDIENTS AND APPEARANCE
ORTHOCARE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73051-0754 Route of Administration DENTAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength ALANINE (UNII: OF5P57N2ZX) SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) MINT (UNII: FV98Z8GITP) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ARGININE (UNII: 94ZLA3W45F) LYSINE (UNII: K3Z4F929H6) SODIUM LAURYL PHOSPHATE (UNII: 9ECT856LYU) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73051-0754-1 125 g in 1 TUBE; Type 0: Not a Combination Product 04/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 04/17/2019 Labeler - Orthosciences, Inc. (044448056)