Label: A AND H PLUS THERABREATH BREATH FRESHNERS- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-676-55, 10237-676-56
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.17% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental decay

  • Warnings

    Do not use if irritation occurs and persists.

    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
    • rinse away toothpaste residue thoroughly after brushing

    adults and children 6 years and older

    brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

  • Inactive Ingredients

    Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, flavor, sodium lauryl sulfate, sodium lauroyl sarcosinate, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide, sodium chlorite.

  • Questions or comments?

    Call 1-800-786-5135 Mon.–Fri. 9am–5pm ET or visit www.myoralcare.com

  • PRINCIPAL DISPLAY PANEL - 156 g Tube Carton

    NEW

    Anticavity
    Fluoride
    Toothpaste

    ARM & HAMMER
    THE STANDARD OF PURITY

    plus

    TheraBreath™
    BREATH FRESHENERS

    helps kill bad breath bacteria*

    whitening

    Invigorating
    Icy Mint

    NET WT
    5.5 OZ (156 g)

    PRINCIPAL DISPLAY PANEL - 156 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    A AND H PLUS THERABREATH BREATH FRESHNERS 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-676
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-676-55156 g in 1 TUBE; Type 0: Not a Combination Product01/01/2024
    2NDC:10237-676-562 in 1 CARTON01/01/2024
    2156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02101/01/2024
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812MANUFACTURE(10237-676)
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