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

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PLAQUE HD ANTICAVITY TOOTHPASTE FRESH MINT FLAVOR

Drug Facts

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

Other information

Inactive ingredients

Water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophsphate, sodium bicarbonate, PVP, sodium benzoate, sodium lauryl sulfate, flavor, carbomer, cellulose gum, annatto extract, xylitol, sodium saccharin, disodium EDTA, blue 1.

Questions?

call toll-free-1-(800) 737-4860

Package Labeling: 57660-000-01

Mint LabelMint Label2

Representative Labeling (57660-000-03)

Mint Tube

Mint Box

PLAQUE HD ANTICAVITY FRESH MINT FLAVOR  PROFESSIONAL PLAQUE-IDENTIFYING
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57660-000
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
ANNATTO (UNII: 6PQP1V1B6O)  
XYLITOL (UNII: VCQ006KQ1E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Fresh Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57660-000-011 in 1 PACKAGE06/10/2013
1116 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:57660-000-021 in 1 PACKAGE06/10/2013
221 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:57660-000-031 in 1 PACKAGE06/10/2013
3116 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02106/10/2013
Labeler - TJA Health LLC (078799634)
Registrant - TJA Health LLC (078799634)
Establishment
NameAddressID/FEIBusiness Operations
TJA Health LLC078799634manufacture(57660-000)

Revised: 12/2023
Document Id: 0d773370-d63a-c88c-e063-6394a90ae4d0
Set id: 98d07260-5274-42b7-bbf8-9683c5e8b624
Version: 15
Effective Time: 20231226
 
TJA Health LLC