IN-7-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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In 7 One

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

IN-7-ONE
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53262-001
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.14 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
TRICLOSAN (UNII: 4NM5039Y5X)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MENTHOL (UNII: L7T10EIP3A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53262-001-01	3 in 1 PACKAGE	06/06/2013	04/08/2019
1		9 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/06/2013	04/08/2019

Labeler - Power Unit Toothbrush Inc (078597674)

Registrant - Power Unit Toothbrush Inc (087597674)

Revised: 4/2019

Document Id: 8607f5b5-fae2-79a1-e053-2991aa0a44a6

Set id: 69af5a4d-de0e-4fc8-8044-de05c6dc07ae

Version: 5

Effective Time: 20190408

Power Unit Toothbrush Inc