BRUSHBUDDIES SHOPKINS ANTICAVITY FLUORIDE- sodium fluoride mouthwash 
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.

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Active Ingredient

Sodium Fluoride 0.05%

Purpose:

Anticavity

Uses:

Helps protect 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:

Other Information

Store in cool and dry place away from direct sun light

Inactive Ingredients:

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Xylitor, Flavor, Acesulfame, Sodium Benzoate, Saccharin Sodium, Rose Red 1

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BRUSHBUDDIES SHOPKINS ANTICAVITY FLUORIDE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-502
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0225 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
ACESULFAME (UNII: MA3UYZ6K1H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ROSE BENGAL AT (UNII: 1IID5XA5GB)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70108-502-01500 g in 1 BOTTLE; Type 0: Not a Combination Product12/03/2016
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(70108-502)

Revised: 12/2016
Document Id: 70f288f2-434d-4b2d-8372-ebb12a05b905
Set id: 9a456198-f0d6-4375-a545-9d07fd3eeca6
Version: 1
Effective Time: 20161203
 
Ashtel Studio Inc