7-IN-ONE- sodium monofluorophosphate gel, dentifrice 
Power Unit Toothbrush 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 monofluorophosphate 0.6778%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Keep out of reach of children

under 6 years of age

Ask a dentist before use if you have

Bleeding or redness lasting more than 2 weeks. Pain swelling, pus, loose teeth or more spacing between teeth. These may be signs of periodontitis, a serious form of gum disease.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision

Children under 2 years of age: Consult a dentist or doctor

Brush teeth throroughly for at least one minute, preferably after each  meal or at least twice a day (morning and evening) or as recommended by a dentist or physician

Other information

Store below 30 degrees C (86 degrees F)

Inactive Ingredients

Sorbitol, hydrated silica, peg-400, sodium lauryl sulfate, sodium saccharin, xanthan gum, triclosan, hydrogen peroxide, sodium benzoate, menthol, FD and C blue no. 1 lake

Questions or comments?

Call 1877-243-4810

MANUFACTURED BY

TOOTHBRUSH
Suzhou Dijiu Plastic Factory Co., Ltd/Suzhou New and Hi-Tech Industrial park, 48 Xujing road, Suzhou China

TOOTHPASTE GEL
Jiangsu Longliqi Group Company Ltd / Changsu LongLiqi Biological Industrial Park, Jiangsu, China

DISTRIBUTED BY

POWERUNIT TOOTHBRUSH INC 5561 NW 72 Ave, Miami FL 33166

WWW.SEVENIN1.COM/WWW.SEVENINONE.NET

MADE IN CHINA

to Report a serious adverse event Contact 18-

Labeling

labeling

7-IN-ONE 
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53262-001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.6778 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 400 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
XANTHAN GUM 
TRICLOSAN 
HYDROGEN PEROXIDE 
SODIUM BENZOATE 
MENTHOL 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:53262-001-013 in 1 PACKAGE
19 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/06/2013
Labeler - Power Unit Toothbrush Inc (078597674)
Registrant - Power Unit Toothbrush Inc (087597674)
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Longliqi Bioscience CO., Ltd.421547530manufacture(53262-001)

Revised: 07/2013
Document Id: d730c32b-411d-44a0-8cb1-a24de198955b
Set id: 69af5a4d-de0e-4fc8-8044-de05c6dc07ae
Version: 2
Effective Time: 20130731
 
Power Unit Toothbrush Inc