JASON POWERSMILE FLUORIDE PEPPERMINT ANTICAVITY- sodium fluoride 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.

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Jason Powersmile Anticavity Whitening Peppermint



Sodium Fluoride 0.24%

Anticavity



use: Prevention of cavities

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 brushing. 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 doctor). Children under 6: To minimize swallowing, use a pea sized amount of paste and supervise rushing until good habits are established. Children under 2, check with a dentist or physician before using.

Glycerin, Water (Aqua), Hydrated Silica, Sodium Laurylglucosides Hydroxypropylsulfonate, Titanium Dioxide, Mentha Piperita (Peppermint) Oil, Chondrus Crispus (Carrageenan), Stevia Rebaudiana Leaf/Stem Extract, Citric Acid, Menthol, Sodium Bicarbonate, Sodium Chloride, Xanthan Gum, Sodium Benzoate

Peppermint Carton

JASON POWERSMILE FLUORIDE PEPPERMINT ANTICAVITY 
sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0600
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
MENTHOL, (+)- (UNII: C6B1OE8P3W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-0600-11 in 1 CARTON02/01/2021
1119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2021
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-0600)

Revised: 6/2023
Document Id: fd27ac30-a2c6-8f94-e053-6394a90a3954
Set id: fd27af7b-6f61-aa84-e053-6294a90aae0a
Version: 1
Effective Time: 20230602
 
The Hain Celestial Group, Inc.