Label: THERABREATH FRESH BREATH ANTICAVITY MILD MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-263-04
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sodium fluoride 0.24% (0.14% W/V fluoride ion)

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental decay.

  • Warnings

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not swallow.

    Supervise children as necessary until capable of using without supervision.

    Adults and children 6 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 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.

  • Other information

    • If spilled on fabrics, wash out immediately.
    • This product was sealed with protective packaging at the laboratory.
    • If seal is missing, do not use.
  • Inactive Ingredients

    Sorbitol, Water, Hydrated Silica, Glycerin, Xylitol, Natural Flavors, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Ammonium Glycyrrhizate, Sodium Benzoate, Citric Acid, Sodium Chlorite, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C).

  • PRINCIPAL DISPLAY PANEL - 113.5 g Tube Carton

    DENTIST FORMULATED
    FIGHTS CAVITIES
    FIGHTS BAD BREATH FOR 12H*

    ANTICAVITY FLUORIDE TOOTHPASTE

    TheraBreath™
    DENTIST FORMULATED
    FRESH BREATH
    TOOTHPASTE

    FIGHTS CAVITIES
    FIGHTS BAD BREATH FOR 12 HOURS*

    AntiCavity
    With Aloe Vera

    Net Wt. 4 oz. • 113.5 g

    MILD MINT

    Read back panel for current directions

    FIGHTS BAD BREATH FOR 12 HOURS*

    PRINCIPAL DISPLAY PANEL - 113.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    THERABREATH FRESH BREATH ANTICAVITY MILD MINT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-263
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-263-041 in 1 CARTON02/08/2024
    1113.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02102/08/2024
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strukmyer Medical078587210MANUFACTURE(10237-263)
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