Skip to Content

THE BLUE TOOTHBRUSH

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 0.0002g
Labeler: New-Light Co., Ltd
NDC Code: 69370-010

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

Active ingredients: 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.

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

THE BLUE TOOTHBRUSH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69370-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.0002 g  in 25 
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL 
XYLITOL 
Packaging
#Item CodePackage Description
1NDC:69370-010-0125 GEL, DENTIFRICE in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2014
Labeler - New-Light Co., Ltd (687405006)
Registrant - New-Light Co., Ltd (687405006)
Establishment
NameAddressID/FEIOperations
New-Light Co., Ltd687405006manufacture(69370-010)

Revised: 01/2015
 
New-Light Co., Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide