FDA.reportPublic FDA data

DENTALUX KIDS ANTICAVITY FLUORIDE TOOTH

Manufacturer
LIDL US, LLC | DENTAL-Kosmetik GmbH & Co. KG
Effective date
2019-04-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:25:21

Label at a glance#

ProductDENTALUX KIDS ANTICAVITY FLUORIDE TOOTH MIXED BERRY
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or physician. Do not swallow To minimize swallowing use a pea sized amount in children under 6 Supervise children until good brushing and rinsing habits are established. For children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.243%

(0.14% W/V FLUORIDE ION)

PURPOSE

OTC - PURPOSE SECTION

ANTICAVITY

USE

INDICATIONS & USAGE SECTION

HELPS PROTECT AGAINST CAVITIES

WARNINGS

WARNINGS SECTION

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or physician.
  • Do not swallow
  • To minimize swallowing use a pea sized amount in children under 6
  • Supervise children until good brushing and rinsing habits are established.
  • For children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, propylene glycol, sodium C14-16 olefin sulfonate, xanthan gum, flavor, sodium saccharin, tocopheryl acetate, sodium methylparaben, mica, titanium dioxide, D&C Red No. 28

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dentalux Kids Mixed Berry Flavor_layoutdentalux Kids Mixed Berry Flavor_layout

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-16171141-161-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C RED NO. 28767IP0Y5NHIACT

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
1bf19fcd-6bde-4ac0-a16d-c8777067bb39d9ce7a56-adaf-4e18-bbe0-8cf1702714ea2020-10-03WarningsExact identifier
spl set id: d9ce7a56-adaf-4e18-bbe0-8cf1702714ea

Reported adverse events (FAERS/openFDA)#

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