FDA.reportPublic FDA data

Emmi-dent Kids

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 00:42:25

Label at a glance#

ProductEmmi-dent Kids
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 0.11% (0.06% 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, sorbitol, hydrated silica, propylene glycol, sodium C-14-16 olefin sulfonate, cellulose gum, aroma, sodium saccharin, sodium methylparaben, CI 77891

Questions?

OTC - QUESTIONS SECTION

1-561-463-6120

SPL UNCLASSIFIED SECTION

Distributed by D&P Sales Services Group, LLC, Florida, 33332
www.emmident-ultrasound.com
CustomerService@emmident-ultrasound.com

PRINCIPAL DISPLAY PANEL - 75 mL Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KIDS

emmi®-dent

Ultrasound Toothpaste

Made in Germany

Principal Display Panel - 75 mL Tube
Principal Display Panel - 75 mL Tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63956-002-022024-12-11C16284748780-11030e365-3d03-111a-e063-dadaa90a10e2Emmi ® -dent Kids
63956-002-022024-07-30C16284748780-11030e365-3d03-111a-e063-dadaa90a10e2Emmi ® -dent Kids
63956-002-022024-01-30C16284748780-11030e365-3d03-111a-e063-dadaa90a10e2Emmi ® -dent Kids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63956-002-02Emmi-dent Kids75 mL in 1 TUBEPASTE, DENTIFRICE754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63956-002EMMI-DENT KIDS (SODIUM FLUORIDE) PASTE, DENTIFRICE [EMAG AG]4Legacy NDC, 1 package rows20241213_4accb6bc-c9f9-4af1-a766-4872d94d08b1.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63956-00263956-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIB
Water059QF0KO0RIACT
Sorbitol506T60A25RIACT
Hydrated SilicaY6O7T4G8P9IACT
Propylene Glycol6DC9Q167V3IACT
Sodium C14-16 Olefin SulfonateO9W3D3YF5UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
Saccharin SodiumSB8ZUX40TYIACT
Methylparaben SodiumCR6K9C2NHKIACT
Titanium Dioxide15FIX9V2JPIACT

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
7a6a4ca9-892d-4e91-aec0-369381f8ed084accb6bc-c9f9-4af1-a766-4872d94d08b12024-12-03WarningsExact identifier
spl id: 7a6a4ca9-892d-4e91-aec0-369381f8ed08
spl set id: 4accb6bc-c9f9-4af1-a766-4872d94d08b1

Reported adverse events (FAERS/openFDA)#

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