Label: ECODENT ULTIMATE ESSENTIAL MOUTHCARE SPARKLING CLEAN MINT- sodium bicarbonate liquid

  • 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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Bicarbonate 2.5%

  • Purpose

    Oral Wound Cleanser/Oral Debriding Agent

  • Uses

    For temporary use in cleansing minor wounds or minor gum inflammation resulting from

    • minor dental procedures
    • dentures
    • orthodontic appliances
    • accidental injury
    • or other irritations of the mouth and gums
  • Warnings

    Do not use this product as an oral wound cleanser for more than 7 days unless directed by a dentist or doctor

    Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling, rash, or fever develops

    Keep out of reach of children If more than used for oral wound cleansing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • 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

    • store at 59° - 86°F (15°-30° C)
  • 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)

  • Questions and Comments?

    Call toll free 1-888-326-3368, Monday – Friday, 9:00 – 5:00, CST

  • SPL UNCLASSIFIED SECTION

    Dist. by ECO-DENT
    P.O. Box 325
    Twin Lakes, WI 53181 USA

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    ECO•DENT®
    PREMIUM ORAL CARE PRODUCTS

    ULTIMATE
    Essential MouthCare®

    Sparkling
    Clean Mint

    DAILYRINSE™
    AND
    ORAL WOUND CLEANSER/
    ORAL DEBRIDING AGENT

    A Blend of 12 Essential Oils with
    CoQ10, Echinacea, Goldenseal,
    & Baking Soda For Sparkling
    Fresh Breath

    Used and recommended by Dentists,
    Oral Surgeons and Periodontists

    Mer•flu•an®

    ALCOHOL FREE
    8 fl. oz. (237 mL)

    Principal Display Panel - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ECODENT ULTIMATE ESSENTIAL MOUTHCARE   SPARKLING CLEAN MINT
    sodium bicarbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76328-223
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76328-223-01236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35606/01/2013
    Labeler - Lotus Brands, Inc. (879022713)
    Registrant - Sun Deep Inc. (189788201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc.189788201MANUFACTURE(76328-223)
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