FRESH MINT PLAQUE HD PROFESSIONAL PLAQUE IDENTIFYING- sodium fluoride paste, dentifrice
TJA Health LLC

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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Plaque HD

Fresh Mint Plaque HD Professional Plaque Identifying

Active Ingredient

Sodium fluoride 0.24% (0.14 w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and over	Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
children under 6 years of age	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 a supervision.
children under 2 years of age	Consult a dentist or doctor.

Inactive Ingredients

WATER, DICALCIUM PHOSHATE, SORBITOL, GLYCERIN, SODIUM LAURYL SULFATE, ANNATTO ( BIXA ORELLANA) SEED EXTRACT, SODIUM HYDROXIDE, NATURAL AND ARTIFICIAL FLAVORS, DISODIUMM EDTA, CELLULOSE GUM, SODIUM SACCHARIN, TETRASODIUM PYROPHOSPHATE, FD AND C BLUE NO.1

Fresh Mint Plaque HD Professional Plaque Identifying Toothpaste 116g (57660-000-01)

+ 1 (800) 401-1214

www.plaquehd.com

TJA HEALTH, LLC JOLIET, IL 60436

MADE IN USA

TARGETOL TECHNOLOGY

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FRESH MINT PLAQUE HD PROFESSIONAL PLAQUE IDENTIFYING
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:57660-000
Route of Administration	DENTAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	0.14 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
SORBITOL
GLYCERIN
SODIUM LAURYL SULFATE
BIXA ORELLANA SEED
SODIUM HYDROXIDE
EDETATE DISODIUM
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM BENZOATE
SACCHARIN SODIUM DIHYDRATE
SODIUM PYROPHOSPHATE
FD&C BLUE NO. 1

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Fresh Mint)	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:57660-000-01	1 in 1 PACKAGE
1		116 g in 1 TUBE
2	NDC:57660-000-02	1 in 1 PACKAGE
2		21 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/10/2013

Labeler - TJA Health LLC (078799634)

Registrant - TJA Health LLC (078799634)

Name	Address	ID/FEI	Business Operations
Establishment
TJA Health LLC		078799634	manufacture(57660-000)

Revised: 9/2013

Document Id: 249c9a0e-c043-4641-9e73-bcd58aa9c4d4

Set id: 98d07260-5274-42b7-bbf8-9683c5e8b624

Version: 6

Effective Time: 20130916

TJA Health LLC