JASON POWERSMILE ANTICAVITY WHITENING PEPPERMINT- sodium monofluorophosphate gel

Jason Powersmile Anticavity Whitening Peppermint by

Drug Labeling and Warnings

Jason Powersmile Anticavity Whitening Peppermint by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.76%

PURPOSE

Anticavity

INDICATIONS & USAGE

use: Prevention of cavities

WARNINGS

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Prevent plaque and tartar buildup with regular drushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or physician). Children under 6: Should use only a pea sized amount of paste and be supervised as necessary. Children under 2, check with a dentist or physician before using.

INACTIVE INGREDIENT

Glycerin, Aqua (Water), Silica, Sodium Cocoyl Glutamate, Xylitol, Mentha Piperita (Peppermint) Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Steam Extract, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Sea Salt, Tocopheryl Acetate, Sodium Bicarbonate, Sodium Magnesium Silicate, Sodium Sulfatre, Ubiquinone (2).

(1) Certified Organic Ingredients

(2) Coenzyme Q10

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JASON POWERSMILE ANTICAVITY WHITENING PEPPERMINT 
sodium monofluorophosphate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0540
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM SULFATE (UNII: 0YPR65R21J)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)
CITRUS MAXIMA SEED (UNII: 083X55C543)
PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
UBIDECARENONE (UNII: EJ27X76M46)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
SEA SALT (UNII: 87GE52P74G)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0540-6	1 in 1 CARTON	10/04/2017
1		170 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	10/04/2017

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		014334364	manufacture(61995-0540)