Ecodent®

Ecodent®
SPL v4
SPL
SPL Set ID 4a95c8c1-db7c-4791-ac58-3eac216a0126
Route
ORAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (25 mg)
Inactive Ingredients
Water Glycerin Polysorbate 20 Aloe Vera Leaf Menthol, Unspecified Form Peppermint Oil Stevia Rebaudiuna Leaf Anethole Echinacea Purpurea Whole Orange Oil, Cold Pressed Citrus X Limon Seed Oil Lavender Oil Sulfated Castor Oil Goldenseal Star Anise Oil Pelargonium Graveolens Flower Oil Rosemary Oil Witch Hazel Bergamot Oil Citrus Paradisi Seed Fennel Oil Clove Oil Basil Oil Rosa X Damascena Flower Oil Ubidecarenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-01

Description

Drug Facts

Purpose

Oral Wound Cleanser/Oral Debriding Agent


Medication Information

Purpose

Oral Wound Cleanser/Oral Debriding Agent

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50570-1

Do not use this product as an oral wound cleanser for more than 7 days unless directed by a dentist or doctor

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
Active Ingredient

Sodium Bicarbonate 2.5%

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) Leaf/Stem 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

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
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)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

Do not use this product as an oral wound cleanser for more than 7 days unless directed by a dentist or doctor

Purpose

Oral Wound Cleanser/Oral Debriding Agent

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
Active Ingredient (Active ingredient)

Sodium Bicarbonate 2.5%

Other Information
  • store at 59° - 86°F (15°-30° C)
Inactive Ingredients (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) Leaf/Stem 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

Stop Use and Ask A Doctor Or Dentist If (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
Principal Display Panel 237 Ml Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

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