Label: TRULY RADIANT CLEAN AND FRESH- sodium monofluorophosphate 0.833% paste, dentifrice

  • NDC Code(s): 10237-668-09, 10237-668-43
  • Packager: Church & Dwight Co., Inc.
  • 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 January 24, 2023

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  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate 0.833%

  • PURPOSE

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use

    aids in the prevention of dental decay

  • WARNINGS

    Warnings

    do not use if irritation occurs and persists

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidently 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 2 years and older - brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

    children under 6 years - instruct in good brushing and rinsing habits (to minimize swallowing)

    children under 2 years - ask a dentist or physician

  • INACTIVE INGREDIENT

    water, sorbitol, calcium pyrophosphate, glycerin, sodium bicarbonate (baking soda), hydrated silica, tetrasodium pyrophosphate, alumina, flavor, sodium saccharin, sodium lauroyl sarcosinate, sodium lauryl sulfate, cellulose gum, xantham gum

  • QUESTIONS

    Questions of comments, call 800 786 5135 or visit trulyradiant . com

  • PRINCIPAL DISPLAY PANEL

    ARM & HAMMER™ THE STANDARD OF PURITY

    Spearmint Naturally Powered by Baking Soda Fluoride Anticavity Toothpaste

    Clean and Fresh

    Truly Radiant™

    Removes More Plaque Advanced Cleaning Neutralizes Acid

    NET WT.

    4.3 OZ. (121g)

    DA2012160_AHFC-00120-03CF

  • INGREDIENTS AND APPEARANCE
    TRULY RADIANT CLEAN AND FRESH 
    sodium monofluorophosphate 0.833% paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-668
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.833 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-668-431 in 1 CARTON05/10/2017
    1121 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-668-091 in 1 CARTON05/10/201710/10/2019
    2121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/15/2015
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-668)
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