Emmi®

Emmi®
SPL v4
SPL
SPL Set ID 1986a759-7dec-4287-884b-556cf314679e
Route
DENTAL
Published
Effective Date 2024-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (199 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Propylene Glycol Potassium Pyrophosphate Xanthan Gum Sodium C14-16 Olefin Sulfonate Mentha Arvensis Leaf Oil Titanium Dioxide Methylparaben Sodium Saccharin Sodium Allantoin Chamomile Three-lobe Sage Menthol, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-15

Description

Drug Facts

Purpose

Anticavity toothpaste


Medication Information

Purpose

Anticavity toothpaste

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 yrs. of age.

If more than used for dental cleaning is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • *
    adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • *
    do not swallow
  • *
    to minimize swallowing use a pea-sized amount in children unter 6
  • *
    supervise children's dental cleaning until good habits are established
  • *
    children under 2 yrs.: ask a dentist
Questions?

1-833-682-8902

Active Ingredient

Sodium Fluoride 0.199% (0.11% w/v fluoride ion)

Inactive Ingredients

water, sorbitol, hydrated silica, propylene glycol, tetrapotassium pyrophosphate, xanthan gum, sodium C-14-16 olefin sulfonate, aroma, mentha arvenis leaf oil, titanium dioxide, sodium methyl paraben, sodium saccharin, allantoin, chamomilla recutita (matricaria) flower extract, salvia triloba leaf extract

Principal Display Panel 75 Ml Tube Carton

emmi® DENT

FRESH

PROFESSIONAL

emmi® DENT

100% ULTRASOUND

Ultrasound Toothpaste

Made in Germany

Ideal

100% Ultraschall®

Made by EMAG Germany


Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 yrs. of age.

If more than used for dental cleaning is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity toothpaste

Directions
  • *
    adults and children 2 yrs. & older: clean teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • *
    do not swallow
  • *
    to minimize swallowing use a pea-sized amount in children unter 6
  • *
    supervise children's dental cleaning until good habits are established
  • *
    children under 2 yrs.: ask a dentist
Questions?

1-833-682-8902

Active Ingredient

Sodium Fluoride 0.199% (0.11% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, propylene glycol, tetrapotassium pyrophosphate, xanthan gum, sodium C-14-16 olefin sulfonate, aroma, mentha arvenis leaf oil, titanium dioxide, sodium methyl paraben, sodium saccharin, allantoin, chamomilla recutita (matricaria) flower extract, salvia triloba leaf extract

Principal Display Panel 75 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 75 ml Tube Carton)

emmi® DENT

FRESH

PROFESSIONAL

emmi® DENT

100% ULTRASOUND

Ultrasound Toothpaste

Made in Germany

Ideal

100% Ultraschall®

Made by EMAG Germany


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)