FDA.reportPublic FDA data

Emmi-dent Whitening

Manufacturer
EMAG AG | Weckerle Cosmetics
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:45:03

Label at a glance#

ProductEmmi-dent Whitening
Active ingredientSodium Fluoride
Label structure10 sections

Dosage and administration

* 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.32% (0.19% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Agua, hydrated silica, hydrogenated starch hydrolysate, propylene glycol, penta sodium triphosphate, tetra potassium pyrophosphate, sodium C14-16 olefin sulfonate, dicalcium phosphate dihydrate, disodium pyrophosphate, silica, cellulose gum, aroma, sodium saccharin, zinc lactate citric acid, sodium sulfate, sodium chloride, benzyl alcohol, CI 42051

Questions?

OTC - QUESTIONS SECTION

1-833-682-8902

SPL UNCLASSIFIED SECTION

Distributed by Ultra Oral Care Inc.,
Spring, Texas, 77386

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

emmi® DENT

WHITENING

emmi® DENT

100% Ultrasound

Ultrasound Toothpaste

Made in Germany

Ideal
100% Ultraschall®
Made by EMAG Germany

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63956-003-032024-12-18C16284748780-1ba0f9c33-5a06-a910-e053-dadaa90a0b85Emmi ® -dent Whitening
63956-003-032024-07-30C16284748780-1ba0f9c33-5a06-a910-e053-dadaa90a0b85Emmi ® -dent Whitening
63956-003-032024-01-30C16284748780-1ba0f9c33-5a06-a910-e053-dadaa90a0b85Emmi ® -dent Whitening
63956-003-032021-11-15C16284748780-1ba0f9c33-5a06-a910-e053-dadaa90a0b85Emmi ® -dent Whitening
63956-003-032021-01-29C16284748780-1ba0f9c33-5a06-a910-e053-dadaa90a0b85Emmi ® -dent Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63956-003-03Emmi-dent Whitening75 mL in 1 TUBEPASTE, DENTIFRICE754
63956-003-03Emmi-dent Whitening1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63956-003EMMI-DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [EMAG AG]4Legacy NDC, 2 package rows20241220_dbc0cfe0-24ef-4ee2-b975-4044624a592f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63956-00363956-003-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIB
Water059QF0KO0RIACT
Hydrated SilicaY6O7T4G8P9IACT
Hydrogenated Starch Hydrolysate27F77DSJ5VIACT
Propylene Glycol6DC9Q167V3IACT
Sodium Tripolyphosphate Anhydrous9SW4PFD2FZIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
Sodium C14-16 Olefin SulfonateO9W3D3YF5UIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
Cellulose GumK679OBS311IACT
Saccharin SodiumSB8ZUX40TYIACT
Zinc Lactate2GXR25858YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
Sodium Sulfate0YPR65R21JIACT
Sodium Chloride451W47IQ8XIACT
Benzyl AlcoholLKG8494WBHIACT
PATENT BLUE V8QE473DV1ZIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
407a5a0e-64d8-43cb-8d24-644261870049dbc0cfe0-24ef-4ee2-b975-4044624a592f2024-12-03WarningsExact identifier
spl id: 407a5a0e-64d8-43cb-8d24-644261870049
spl set id: dbc0cfe0-24ef-4ee2-b975-4044624a592f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.