JASON HEALTHY MOUTH ANTICAVITY TARTAR CONTROL TEA TREE CINNAMON- sodium monofluorophosphate gel 
The Hain Celestial Group, Inc.

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.

----------

Healthy Mouth Toothgel

Anticavity

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

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.

Glycerin, Aqua (Water), Hydrated Silica, Sodium Cocoyl Glutamate, Xylitol, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil (1), Melia Azadirachta Seed Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Carum Petroselinum (Parsley) Extract, Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Stem Extract, Ascorbic Acid, Tocopheryl Acetate, Calcium Carbonate, Cellulose Gum, Citric Acid, Menthol, Sea Salt, Sodium Bicarbonate, Sodium Magnesium Silicate, Ubiquinone, Eugenol

(1) Certified Organic Ingredients

(2) Coenzyme Q10

Use: Prevention of cavities

Sodium Monofluorophosphate 0.76%

carton labeltube label

JASON HEALTHY MOUTH ANTICAVITY TARTAR CONTROL TEA TREE CINNAMON 
sodium monofluorophosphate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0525
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
CLOVE OIL (UNII: 578389D6D0)  
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
XYLITOL (UNII: VCQ006KQ1E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
PARSLEY (UNII: 58FMD0Q0EV)  
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)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EUGENOL (UNII: 3T8H1794QW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-0525-61 in 1 CARTON09/20/2017
1170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/20/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (081512382)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-0525)

Revised: 4/2021
Document Id: bfc9048a-5df5-3220-e053-2a95a90ac677
Set id: 6627017b-d533-1b67-e053-2a91aa0afd54
Version: 4
Effective Time: 20210412
 
The Hain Celestial Group, Inc.