KANGAROOORALCARETOOTHPASTE- sodium fluoride paste 
Kangaroo Oral Care, LLC

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.

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Kanagaroo Toothbrush Kit

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

Kangaroo 2.01. 19 final

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)

Revised: 1/2019
Document Id: 80ca3324-10ba-89cc-e053-2a91aa0aff3d
Set id: 80ca3324-10b8-89cc-e053-2a91aa0aff3d
Version: 3
Effective Time: 20190131
 
Kangaroo Oral Care, LLC