OTC Medication Information: EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon

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.

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

purified water, glycerin (vegetable), polysorbate 20, Cinnamomum cassia (cinnamon) oil, Cinnamomum zeylanicum (cinnamon) leaf oil, witch hazel distillate, Stevia rebaudiana (stevia) extract, Aloe barbadensis (aloe vera) leaf juice (decolorized), Citrus paridisi (grapefruit) seed extract, ubiquinone (CoQ10), Echinacea purpurea (echinacea) extract, Hydrastis canadensis (goldenseal) leaf extract, Melaleuca alternifolia (tea tree) oil, anethole, Pelargonium graveolens (geranium) oil, Mentha piperita (peppermint) oil, menthol, Citrus aurantium dulcis (orange) oil, Citrus medica limonum (lemon) oil, Illicium verum (anise) oil, Citrus bergamia (bergamot) oil, Ocimum basilicum (basil) oil, Foeniculum vulgare (fennel) oil, Rosmarinus officinalis (rosemary) oil, rose water concentrate, sulfated castor oil, Lavandula angustifolia (lavender) oil

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 Type HUMAN OTC DRUG Item Code (Source) NDC:76328-221 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 25 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN POLYSORBATE 20 CHINESE CINNAMON OIL CINNAMON LEAF OIL WITCH HAZEL STEVIA REBAUDIUNA LEAF ALOE VERA LEAF CITRUS PARADISI SEED UBIDECARENONE ECHINACEA PURPUREA GOLDENSEAL TEA TREE OIL ANETHOLE PELARGONIUM GRAVEOLENS FLOWER OIL PEPPERMINT OIL MENTHOL, UNSPECIFIED FORM ORANGE OIL CITRUS X LIMON SEED OIL STAR ANISE OIL BERGAMOT OIL BASIL OIL FENNEL OIL ROSEMARY OIL SULFATED CASTOR OIL LAVENDER OIL ROSA X DAMASCENA FLOWER OIL

Product Characteristics Color Score Shape Size Flavor CINNAMON (Spicy-Cool) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76328-221-01 236 mL in 1 BOTTLE, PLASTIC None

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	Operations
Sun Deep Inc.		189788201	MANUFACTURE (76328-221)

Revised: 09/2019 Lotus Brands, Inc.