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 LabelPrincipal 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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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