ECODENT ULTIMATE ESSENTIAL MOUTHCARE  SPICY-COOL CINNAMON- 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®
Spicy-Cool Cinnamon

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, 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

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®

Spicy-Cool
Cinnamon

DAILYRINSE™
AND
ORAL WOUND CLEANSER/
ORAL DEBRIDING AGENT

A Blend of 14 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   SPICY-COOL CINNAMON
sodium bicarbonate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76328-221
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)  
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    
ShapeSize
FlavorCINNAMON (Spicy-Cool) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76328-221-01236 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(76328-221)

Revised: 1/2022
Document Id: fff6588e-b4c0-4a0d-bdef-8bcb1b5630e4
Set id: 6703b29d-cdc9-4c74-91c0-fb0c98dd043e
Version: 3
Effective Time: 20220114
 
Lotus Brands, Inc.