Label: JASON SEA FRESH ANTICAVITY STRENGTHENING DEEP SEA SPEARMINT- sodium monofluorophosphate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-0104-6 - 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 June 7, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Adults and children 2 years of age or older: brush teeth throughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Instruct children under 6 years of age in good brushing and rinsing habits (to monomize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6: Use a pea sized amount. Children under 2: Ask a dentist or physician.
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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, Ubiquinone (2).
(1) Certified Organic Ingredients
(2) Coenzyme Q10
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JASON SEA FRESH ANTICAVITY STRENGTHENING DEEP SEA SPEARMINT
sodium monofluorophosphate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (MONOFLUOROPHOSPHATE ION - UNII:4964UZ79MI) SODIUM MONOFLUOROPHOSPHATE 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength 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) CITRUS MAXIMA SEED (UNII: 083X55C543) PARSLEY (UNII: 58FMD0Q0EV) PERILLA FRUTESCENS SEED (UNII: 8M62PUD356) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SPEARMINT OIL (UNII: C3M81465G5) APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X) 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:61995-0104-6 1 in 1 CARTON 1 170 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/20/2011 Labeler - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture
