BRUSHBUDDIES SHOPKINS ANTICAVITY TOOTH- sodium monofluorophosphate paste, dentifrice 
Ashtel Studio Inc

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.

----------

Active Ingredient

Sodium Monofluorophosphate 0.5%

Purpose:

Anticavity

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 under 6 years of age

Directions:

Children under 2 years of age:

Inactive Ingredients:

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

image description

BRUSHBUDDIES SHOPKINS ANTICAVITY TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.066 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)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70108-501-01119 g in 1 TUBE; Type 0: Not a Combination Product11/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/28/2016
Labeler - Ashtel Studio Inc (148689180)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Nanhai JiaChun Biology Engineering Co., Ltd527935253manufacture(70108-501)

Revised: 11/2016
Document Id: a79b8c3d-2a7f-49d9-9a81-50ffc4e86c15
Set id: 95bf8421-e166-42f7-8547-ba6358d44051
Version: 1
Effective Time: 20161129
 
Ashtel Studio Inc