KROGER SENSITIVE (FLUORIDE) PASTE, DENTIFRICE [KROGER COMPANY]

KROGER SENSITIVE (FLUORIDE) PASTE, DENTIFRICE [KROGER COMPANY]
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NDC 30142-148-82, 30142-148-89
Set ID a20845af-0217-4239-9078-eae4a63d1b26
Category HUMAN OTC DRUG LABEL
Packager Kroger Company
Generic Name
Product Class
Product Number
Application Number PART356
  • Active ingredients / Purpose

    Potassium nitrate 5%....................................................Antihypersensitivity

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

  • Uses

    aids in the prevention of dental cavities

  • WARNINGS

    If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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

  • Directions

    Adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

  • DOSAGE & ADMINISTRATION

    Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

  • Other Information

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

  • Inactive ingredients

    cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

  • INGREDIENTS AND APPEARANCE
    KROGER  SENSITIVE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-148
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) NITRATE ION5.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-148-891 in 1 CARTON
    1NDC:30142-148-82113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/20/2011
    Labeler - Kroger Company (006999528)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead126440440manufacture(30142-148) , pack(30142-148)

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