Label: JASON SEA FRESH ANTICAVITY DEEP SEA SPEARMINT- sodium monofluorophosphate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-0530-6 - Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 12, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Prevent plaque and tartarbuildup 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.
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INACTIVE INGREDIENT
Glycerin, Aqua (Water), Silica, Sodium Cocoyl Glutamate, Xylitol, Mentha Viridis (Spearmint) Leaf Oil, Aloe Barbadensis Leaf Juice (1),Aphanizomenon Flos-Aquae Powder, Bambusa Arundinacea Stem Powder, Carum Petroselinum (Parsley) Extract,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
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INGREDIENTS AND APPEARANCE
JASON SEA FRESH ANTICAVITY DEEP SEA SPEARMINT
sodium monofluorophosphate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0530 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 CHLORELLA PYRENOIDOSA (UNII: 591BV50NV8) 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) PARSLEY (UNII: 58FMD0Q0EV) PERILLA FRUTESCENS SEED (UNII: 8M62PUD356) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SPEARMINT OIL (UNII: C3M81465G5) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0530-6 1 in 1 CARTON 09/29/2017 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 09/29/2017 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (081512382) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-0530)