FRESHDENT KIDS STRAWBERRY ANTICAVITY TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [FRESHDENT LLC]

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FRESHDENT KIDS STRAWBERRY ANTICAVITY TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [FRESHDENT LLC]
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NDC 69338-001-01
Set ID d891b45d-d0a0-4f97-ba42-b7c85765f494
Category HUMAN OTC DRUG LABEL
Packager FreshDent LLC
Generic Name
Product Class
Product Number
Application Number PART355
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  • Active Ingredients

    Sodium Fluoride 0.188% (0.065% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

  • Warnings

  • Keep out of Reach of children

    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

    • Adults and children 2 years of age and older: Brush teeth thoroughly, 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 minimize swallowing). Supervise children as necessary until capable of using without supervision.

    • Children under 2 years of age: Consult a dentist or doctor.
  • Inactive Ingredients

    Sorbitol, Glycerin, Water,Silica, Carboxymethyl Cellulose, Lauryl Sulfate, Sodium Saccharin, Diazolidinyl Urea, Strawberry Flavor, Menthol, D &C Red No. 33.

  • Questions?

    +1-512-653-8814

  • Package Label

    Strawberry Anticavity toothpaste

    FreshDent           Kids

    we care

    Net Wt. 0.85 oz (24 g)

    Distributed by: FreshDent LLC Crockett, TX 75835 www.freshdent.net Made in Egypt

    Box

    Tube

  • INGREDIENTS AND APPEARANCE
    FRESHDENT KIDS STRAWBERRY ANTICAVITY TOOTH 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69338-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.65 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69338-001-011 in 1 CARTON
    124 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/06/2014
    Labeler - FreshDent LLC (079303265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss Egyptian Co. For Oral Care Products and Cosmetics366442234manufacture(69338-001)
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