KROGER COMPANY RADIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [KROGER COMPANY]

KROGER COMPANY RADIANT WHITE (FLUORIDE) PASTE, DENTIFRICE [KROGER COMPANY]
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NDC 30142-621-62, 30142-621-69
Set ID fef2b4ad-cee9-480a-8091-469dd572616b
Category HUMAN OTC DRUG LABEL
Packager Kroger Company
Generic Name
Product Class
Product Number
Application Number PART355
  • 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 CARTON05/29/2014
    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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