Label: THERABREATH PLUS FRESH BREATH- sodium fluoride paste, dentifrice
- NDC Code(s): 10237-264-04
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
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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.
- 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, Zinc Gluconate, Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Ubiquinone (COQ10), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)
- PRINCIPAL DISPLAY PANEL - 113.5 g Tube Label
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INGREDIENTS AND APPEARANCE
THERABREATH PLUS FRESH BREATH
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-264 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) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM BENZOATE (UNII: OJ245FE5EU) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CHLORITE (UNII: G538EBV4VF) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) ASCORBIC ACID (UNII: PQ6CK8PD0R) UBIDECARENONE (UNII: EJ27X76M46) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) SPEARMINT OIL (UNII: C3M81465G5) Product Characteristics Color WHITE Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-264-04 113.5 g in 1 TUBE; Type 0: Not a Combination Product 02/28/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M021 01/01/2024 Labeler - Church & Dwight Co., Inc. (001211952)
