Label: KROGER COMPANY RADIANT WHITE- fluoride paste, dentifrice

  • NDC Code(s): 30142-621-62, 30142-621-69
  • Packager: Kroger Company
  • 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 11, 2023

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  • Active ingredient

    Sodium Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)..................................Purpose: Anticavity

  • Uses

    aids in the prevention of dental caviites

  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

  • Directions

    Adults and children 2 years of age and older: brush teeth thorughly 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 avoid swallowing). Supervise children as necessary until capable of using without supervision.

  • Other Information

    Store in a cool dry place. Keep tube capped when not in use.

  • Inactive ingredients

    glycerin, dicalcium phosphate, PEG-12, PVP, PEG/PPG 116/66 copolymer, hydrated silica, hydrogen peroxide, propylene glycol, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: brush teeth throuoghly, preferably after every meal or at least twice a day, or as directed by a dentist or doctor.

  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

  • INGREDIENTS AND APPEARANCE
    KROGER COMPANY  RADIANT WHITE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-621
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Product Characteristics
    Colorwhite (White) Score    
    ShapeSize
    FlavorMINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-621-691 in 1 CARTON01/11/2023
    1NDC:30142-621-62155 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/24/2014
    Labeler - Kroger Company (006999528)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(30142-621) , pack(30142-621)
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