Label: KANGAROOORALCARETOOTHPASTE- sodium fluoride paste

  • 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 31, 2019

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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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