NDC | 61995-0104-6 |
Set ID | 8ea1e3ae-2de9-4ba6-87fc-52b535831660 |
Category | HUMAN OTC DRUG LABEL |
Packager | The Hain Celestial Group, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART355 |
- 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