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

PLAQUE HD ANTICAVITY FRESH MINT FLAVOR by

Drug Labeling and Warnings

PLAQUE HD ANTICAVITY FRESH MINT FLAVOR by is a Otc medication manufactured, distributed, or labeled by TJA Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PLAQUE HD ANTICAVITY TOOTHPASTE FRESH MINT FLAVOR

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 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: Consult a dentist or doctor.
  

Inactive Ingredients

WATER, HYDRATED SILICA, SORBITOL, GLYCERIN, TETRASODIUM PYROPHOSPHATE, CELLULOSE GUM, SODIUM BENZOATE, SODIUM LAURYL SULFATE, DISODIUM EDTA, CARBOMER, SODIUM SACCHARIN, NATURAL AND ARTIFICIAL FLAVORS, ANNATTO EXTRACT, FDandC BLUE NO.1

Representative Labeling (

57660-000-01)

Representative Labeling (

57660-000-03)

INGREDIENTS AND APPEARANCE

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
BIXA ORELLANA SEED (UNII: O87354RZ5A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57660-000-01	1 in 1 PACKAGE	06/10/2013
1		116 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 57660-000-02	1 in 1 PACKAGE	06/10/2013
2		21 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 57660-000-03	1 in 1 PACKAGE	06/10/2013
3		116 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - TJA Health LLC (078799634)

Registrant - TJA Health LLC (078799634)

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