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NDC 76328-0223-01 EcoDent Ultimate Essential Mouthcare 25 mg/mL Details

EcoDent Ultimate Essential Mouthcare 25 mg/mL

EcoDent Ultimate Essential Mouthcare is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Lotus Brands, Inc.. The primary component is SODIUM BICARBONATE.

MedlinePlus Drug Summary

Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 76328-0223-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate

Product Information

NDC	76328-0223
Product ID	76328-223_774a2cef-b101-4dd4-be22-a070e87a2a6e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	EcoDent Ultimate Essential Mouthcare
Proprietary Name Suffix	Sparkling Clean Mint
Non-Proprietary Name	SODIUM BICARBONATE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/mL
Substance Name	SODIUM BICARBONATE
Labeler Name	Lotus Brands, Inc.
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 76328-0223-01 (76328022301)

Pricing Information	N/A
NDC Package Code	76328-223-01
Billing NDC	76328022301
Package	236 mL in 1 BOTTLE, PLASTIC (76328-223-01)
Marketing Start Date	2013-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a95c8c1-db7c-4791-ac58-3eac216a0126 Details

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

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76328-223-01	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	06/01/2013

Labeler - Lotus Brands, Inc. (879022713)

Registrant - Sun Deep Inc. (189788201)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Deep Inc.		189788201	MANUFACTURE(76328-223)

Revised: 1/2022

Document Id: 774a2cef-b101-4dd4-be22-a070e87a2a6e

Set id: 4a95c8c1-db7c-4791-ac58-3eac216a0126

Version: 3

Effective Time: 20220114

Search by Drug Name or NDC

NDC 76328-0223-01 EcoDent Ultimate Essential Mouthcare 25 mg/mL Details

EcoDent Ultimate Essential Mouthcare 25 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 76328-0223-01 (76328022301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4a95c8c1-db7c-4791-ac58-3eac216a0126 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Stop use and ask a doctor or dentist if

Directions

Other Information

Inactive ingredients

Questions and Comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

INGREDIENTS AND APPEARANCE

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