THE WHITE TOOTHBRUSH- sodium fluoride gel, dentifrice 
New-Light 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

Active ingredient: Sodium Fluoride 0.22%

INACTIVE INGREDIENT

Inactive ingredients: D-Sorbitol solution, Doncentrated Glycerin, Sodium Lauryl Sarcosinate, Peppermint oil, L-menthol, Methylparaben, Xylitol, Ascorbic acid, Tocopherol Acetate, Brilliant Blue FCF, Water

PURPOSE

Purpose: Aids in the prevention of dental decay

WARNINGS

Warnings: Supervise children using the toothbrush. Coated toothpaste is initial use, 'The Blue' toothbrush is reusable with toothpaste after initial use. Please change the toothbrush every 15days or when the bristles are worn out. Store in a cool place out of humidity and direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of the reach of children under 6 years of age.

How to use

How to use: Use to remove the packaging and buried in a little water on the brush head.

How to use

How to use: Use to remove the packaging and buried in a little water on the brush head.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

Image of carton

THE WHITE TOOTHBRUSH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69370-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0002 g  in 25 
Inactive Ingredients
Ingredient NameStrength
Peppermint oil (UNII: AV092KU4JH)  
Xylitol (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69370-020-0125 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/02/2015
Labeler - New-Light Co., Ltd (687405006)
Registrant - New-Light Co., Ltd (687405006)
Establishment
NameAddressID/FEIBusiness Operations
New-Light Co., Ltd687405006manufacture(69370-020)

Revised: 2/2015
Document Id: 2f668e52-11d2-4022-9b2d-e966f0af4d18
Set id: e66dfde3-87af-4137-b6f8-8de5fdd115ca
Version: 1
Effective Time: 20150224
 
New-Light Co., Ltd