KANGAROOORALCARETOOTHPASTE (SODIUM FLUORIDE) PASTE [KANGAROO ORAL CARE, LLC]

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KANGAROOORALCARETOOTHPASTE (SODIUM FLUORIDE) PASTE [KANGAROO ORAL CARE, LLC]
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NDC 72840-1901-1
Set ID 80ca3324-10b8-89cc-e053-2a91aa0aff3d
Category HUMAN OTC DRUG LABEL
Packager Kangaroo Oral Care, LLC
Generic Name
Product Class
Product Number
Application Number PART355
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  • Active Ingredient

    sodium fluoride 0.24%（0.14% w/v fluoride ion）

  • Purpose

    Anticavitytoothpaste

  • Use

    helps aid in the prevention of dental cavities.

  • Warning

    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

    Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

    do not swallow

    to minimize swallowing use a pea-sized amount in children under 6

    supervise children as necessary until capable of using without supervision

  • Inactive Ingredients

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

    Keep out of reach of children under 6 years of age

  • PRINCIPAL DISPLAY PANEL

    Kangaroo 2.01. 19 final

  • INGREDIENTS AND APPEARANCE
    KANGAROOORALCARETOOTHPASTE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72840-1901
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL, L- (UNII: 01Q0586BG1)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72840-1901-124 g in 1 KIT; Type 1: Convenience Kit of Co-Package02/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/04/2019
    Labeler - Kangaroo Oral Care, LLC (081040249)
    Registrant - Kangaroo Oral Care, LLC (081040249)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangaroo Oral Care, LLC081040249label(72840-1901)
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