Ecodent Ultimate Essential Mouthcare Liquid
FDA Label NDC 76328-221

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lotus Brands, Inc. for the product Ecodent Ultimate Essential Mouthcare (NDC 76328-221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - do not use, stop use and ask a doctor or dentist if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by ECO-DENT
1100 Lotus Dr.,
Silver Lake, WI 53170 USA

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

Otc - Do Not Use

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

Water, Sulfated castor oil, menthol, Cinnamomum cassia leaf oil, Mentha piperita (peppermint) oil, Echinacea purpurea extract, Hydrastis canadensis (golden seal) extract, Stevia rebaudiana extract, Melaleuca alternifolia (tea tree) leaf oil, Ubiquinone (CoQ10), Citrus aurantium dulcis (orange) oil, Citrus medica limonum (lemon) peel oil, Foeniculum vulgare (fennel) oil, Illicium verum (anise) oil, Pelargonium graveolens flower oil, Citrus aurantium bergamia (bergamot) fruit oil, Lavandula angustifolia (lavender) oil, Rosmarinus officinalis (rosemary) leaf oil, Ocimum basilicum (basil) oil, Rose flower oil.

Questions And Comments?

Call toll free 1-888-326-3368, Monday – Friday, 9:00 – 5:00, CST

Principal Display Panel - 237 Ml Bottle Label

ECO•DENT®
PREMIUM ORAL CARE PRODUCTS

©ECO-DENT

Spicy-Cool Cinnamon
ULTIMATE
Essential Mouth Care®
NATURAL
DAILY RINSE™
AND
ORAL WOUND CLEANSER/
ORAL DEBRIDING AGENT

A Blend of 14 Essential Oils with
CoQ-10, Echinacea, Goldenseal,
& Baking Soda For Sparkling
Fresh Breath

Used and recommended by Dentists,
Oral Surgeons and Periodontists

ALCOHOL FREE

Mer•flu•an®

8 f l oz / 237mL

Principal Display Panel (237 mL Bottle Label)

Principal Display Panel (237 mL Bottle Label)

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