Label: ECODENT ULTIMATE ESSENTIAL MOUTHCARE SPARKLING CLEAN MINT- sodium bicarbonate liquid
- NDC Code(s): 76328-223-01
- Packager: Lotus Brands, Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 14, 2022
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- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- Adults and children 2 years of age and older: Swish 2-3 capfuls around in mouth over affected area for at least 1 minute and then spit it out. Use up to 4 times daily or as directed by a dentist or doctor
- Children under 12 should be supervised in the use of the product
- Children under 2 years of age: Consult a dentist or doctor
- Other Information
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Inactive ingredients
Aqua (Purified Water), Glycerin (Vegetable), Polysorbate 20, Aloe Barbadensis (Aloe Vera) Leaf Juice (Decolorized), Menthol, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana (Stevia) Extract, Anethole, Echinacea Purpurea (Echinacea) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Ricinus Communis (Castor) Seed Oil, Hydrastis Canadensis (Goldenseal) Leaf Extract, Pimpinella Anisum (Anise) Fruit Oil, Pelargonium Graveolens (Geranium) Oil, Rosmarinus Officinalis (Rosemary) Oil, Hamamelis Virginiana (Witch Hazel) Water, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Paradisi (Grapefruit) Seed Extract, Foeniculum Vulgare (Fennel) Oil, Eugenia Caryophyllus (Clove) Flower Oil, Ocimum Basilicum (Basil) Oil, Rosewater Concentrate, Ubiquinone (CoQ10)
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PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
ECO•DENT®
PREMIUM ORAL CARE PRODUCTSULTIMATE
Essential MouthCare®Sparkling
Clean MintDAILYRINSE™
AND
ORAL WOUND CLEANSER/
ORAL DEBRIDING AGENTA Blend of 12 Essential Oils with
CoQ10, Echinacea, Goldenseal,
& Baking Soda For Sparkling
Fresh BreathUsed and recommended by Dentists,
Oral Surgeons and PeriodontistsMer•flu•an®
ALCOHOL FREE
8 fl. oz. (237 mL) -
INGREDIENTS AND APPEARANCE
ECODENT ULTIMATE ESSENTIAL MOUTHCARE SPARKLING CLEAN MINT
sodium bicarbonate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76328-223 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALOE VERA LEAF (UNII: ZY81Z83H0X) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PEPPERMINT OIL (UNII: AV092KU4JH) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) ANETHOLE (UNII: Q3JEK5DO4K) ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) CITRUS X LIMON SEED OIL (UNII: T78Z8273XO) LAVENDER OIL (UNII: ZBP1YXW0H8) SULFATED CASTOR OIL (UNII: 75T1HFY189) GOLDENSEAL (UNII: ZW3Z11D0JV) STAR ANISE OIL (UNII: 6RXP35EIRE) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) ROSEMARY OIL (UNII: 8LGU7VM393) WITCH HAZEL (UNII: 101I4J0U34) BERGAMOT OIL (UNII: 39W1PKE3JI) CITRUS PARADISI SEED (UNII: 12F08874Y7) FENNEL OIL (UNII: 59AAO5F6HT) Clove Oil (UNII: 578389D6D0) BASIL OIL (UNII: Z129UMU8LE) ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) UBIDECARENONE (UNII: EJ27X76M46) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76328-223-01 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 06/01/2013 Labeler - Lotus Brands, Inc. (879022713) Registrant - Sun Deep Inc. (189788201) Establishment Name Address ID/FEI Business Operations Sun Deep Inc. 189788201 MANUFACTURE(76328-223)