Label: THERABREATH FRESH BREATH- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 72551-250-01, 72551-250-02 - Packager: Dr. Harold Katz, LLC
- 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 February 4, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Directions
Adults & 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 swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
- Warnings
- Other information
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Inactive Ingredients
Sorbitol, Water (Aqua), Hydrated Silica, Glycerin (from vegetable sources), Xylitol, Natural Flavor, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Chlorite (OXYD-8™), Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)
- TheraBreath Fresh Breath
- Mild Mint Travel Size
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INGREDIENTS AND APPEARANCE
THERABREATH FRESH BREATH
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72551-250 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.0024 g in 1 g Inactive Ingredients Ingredient Name Strength SPEARMINT (UNII: J7I2T6IV1N) MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2) ASCORBIC ACID (UNII: PQ6CK8PD0R) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) SODIUM CHLORITE (UNII: G538EBV4VF) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white (Clear) Score Shape Size Flavor MINT (Mild Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72551-250-01 1 in 1 PACKAGE 10/04/2018 1 113.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:72551-250-02 21.3 g in 1 TUBE; Type 0: Not a Combination Product 10/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/04/2018 Labeler - Dr. Harold Katz, LLC (965507767)
