PLAQUE HD ANTICAVITY BERRY BUBBLE GUM FLAVOR PROFESSIONAL PLAQUE-IDENTIFYING- sodium fluoride paste, dentifrice 
TJA Health LLC

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PLAQUE HD ANTICAVITY TOOTHPASTE BERRY BUBBLE GUM 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 (57660-001-01)

Box LabelBox Label2

Representative Labeling (57660-001-02)

Box

Tube

PLAQUE HD ANTICAVITY BERRY BUBBLE GUM FLAVOR  PROFESSIONAL PLAQUE-IDENTIFYING
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57660-001
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
FlavorBERRY, BUBBLE GUM (Berry Bubble Gum Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57660-001-011 in 1 PACKAGE03/19/2014
1116 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:57660-001-021 in 1 PACKAGE03/19/2014
2116 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02103/19/2014
Labeler - TJA Health LLC (078799634)
Registrant - TJA Health LLC (078799634)
Establishment
NameAddressID/FEIBusiness Operations
TJA Health LLC078799634manufacture(57660-001)

Revised: 12/2023
Document Id: 0d77541c-d75e-96b1-e063-6294a90ac54b
Set id: 7f24bbf8-9694-4bfd-a2d9-b00429f4c50f
Version: 8
Effective Time: 20231226
 
TJA Health LLC