ECODENT ULTIMATE ESSENTIAL MOUTHCARE SPARKLING CLEAN MINT- sodium bicarbonate liquid

EcoDent Ultimate Essential Mouthcare by

Drug Labeling and Warnings

EcoDent Ultimate Essential Mouthcare by is a Otc medication manufactured, distributed, or labeled by Lotus Brands, Inc., Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

ECODENT®
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

Merfluan®

ALCOHOL FREE
8 fl. oz. (237 mL)

INGREDIENTS AND APPEARANCE

ECODENT ULTIMATE ESSENTIAL MOUTHCARE   SPARKLING CLEAN MINT
sodium bicarbonate liquid

Product 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 (UNII: QI7G114Y98)
ORANGE OIL (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)