Label: ECODENT ULTIMATE ESSENTIAL MOUTHCARE SPICY-COOL CINNAMON- sodium bicarbonate liquid
- NDC Code(s): 76328-221-01
- Packager: Lotus Brands, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 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, Cinnamomum Cassia (Cassia) Oil, Stevia Rebaudiana (Stevia) Extract, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, 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, Rosmarinus Officinalis (Rosemary) Leaf/Stem Oil, Hamamelis Virginiana (Witch Hazel) Water, Pelargonium Graveolens (Geranium) Oil, Citrus Paradisi (Grapefruit) Seed Extract, Anethole, Eugenia Caryophyllus (Clove) Flower Oil, Ocimum Basilicum (Basil) Oil, Foeniculum Vulgare (Fennel) Oil, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Ubiquinone (CoQ10), Rosewater Concentrate
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PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
ECO•DENT®
PREMIUM ORAL CARE PRODUCTSULTIMATE
Essential MouthCare®Spicy-Cool
CinnamonDAILYRINSE™
AND
ORAL WOUND CLEANSER/
ORAL DEBRIDING AGENTA Blend of 14 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 SPICY-COOL CINNAMON
sodium bicarbonate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76328-221 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) CHINESE CINNAMON OIL (UNII: A4WO0626T5) CINNAMON LEAF OIL (UNII: S92U8SQ71V) WITCH HAZEL (UNII: 101I4J0U34) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRUS PARADISI SEED (UNII: 12F08874Y7) UBIDECARENONE (UNII: EJ27X76M46) ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98) GOLDENSEAL (UNII: ZW3Z11D0JV) CLOVE OIL (UNII: 578389D6D0) ANETHOLE (UNII: Q3JEK5DO4K) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) CITRUS X LIMON SEED OIL (UNII: T78Z8273XO) STAR ANISE OIL (UNII: 6RXP35EIRE) BERGAMOT OIL (UNII: 39W1PKE3JI) BASIL OIL (UNII: Z129UMU8LE) FENNEL OIL (UNII: 59AAO5F6HT) ROSEMARY OIL (UNII: 8LGU7VM393) SULFATED CASTOR OIL (UNII: 75T1HFY189) LAVENDER OIL (UNII: ZBP1YXW0H8) ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) Product Characteristics Color Score Shape Size Flavor CINNAMON (Spicy-Cool) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76328-221-01 236 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(76328-221)