ECODENT ULTIMATE ESSENTIAL MOUTHCARE  SPARKLING CLEAN MINT- sodium bicarbonate liquid 
Lotus Brands, Inc.

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.

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EcoDent® Ultimate Essential Mouthcare®
Sparkling Clean Mint

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

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

Other Information

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

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
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)

Revised: 1/2022
Document Id: 774a2cef-b101-4dd4-be22-a070e87a2a6e
Set id: 4a95c8c1-db7c-4791-ac58-3eac216a0126
Version: 3
Effective Time: 20220114
 
Lotus Brands, Inc.