BRUSHBUDDIES THOMAS FRIENDS ANTICAVITY FLURORIDE TOOTH- sodium monofluorophosphate paste, dentifrice 
Foshan Nanhai JiaChun Biology Engineering Co., Ltd

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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Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose:

Anticavity Toothpaste

Uses: Help protect teeth and roots against cavities

Warnings:

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately

Keep out of reach of children

Directions:

Children under 2 years of age:

Inactive Ingredients:

Sorbitor, Water, Silica, Sodium N-Lauroylsarcosinate, Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red 1

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BRUSHBUDDIES THOMAS FRIENDS ANTICAVITY FLURORIDE TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71106-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71106-004-01119 g in 1 TUBE; Type 0: Not a Combination Product08/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/02/2018
Labeler - Foshan Nanhai JiaChun Biology Engineering Co., Ltd (527935253)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Nanhai JiaChun Biology Engineering Co., Ltd527935253manufacture(71106-004)

Revised: 8/2018
Document Id: ad93c122-0fa1-4093-8f3f-0aa2b975fcd0
Set id: e98b40d8-bf83-4a25-9514-bb4500099fc6
Version: 1
Effective Time: 20180802
 
Foshan Nanhai JiaChun Biology Engineering Co., Ltd