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 overBrush 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 ageInstruct 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 ageConsult a dentist or doctor.

Inactive Ingredients

WATER, DICALCIUM PHOSHATE, SORBITOL, GLYCERIN, TETRASODIUM PYROPHOSPHATE, CELLULOSE GUM, SODIUM BENZOATE, SODIUM LAURYL SULFATE, DISODIUMM EDTA, CARBOMER, SODIUM SACCHARIN, NATURAL AND ARTIFICIAL FLAVORS, ANNATTO ( BIXA ORELLANA) SEED EXTRACT, 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57660-000
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
SORBITOL 
GLYCERIN 
SODIUM PYROPHOSPHATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
EDETATE DISODIUM 
SACCHARIN SODIUM 
BIXA ORELLANA SEED 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57660-000-011 in 1 PACKAGE
1116 g in 1 TUBE
2NDC:57660-000-021 in 1 PACKAGE
221 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/10/2013
Labeler - TJA Health LLC (078799634)
Registrant - TJA Health LLC (078799634)
Establishment
NameAddressID/FEIBusiness Operations
TJA Health LLC078799634manufacture(57660-000)

Revised: 2/2014
Document Id: b091e5e2-843f-4db4-91b7-653c2bc4fd85
Set id: 98d07260-5274-42b7-bbf8-9683c5e8b624
Version: 7
Effective Time: 20140206
 
TJA Health LLC