FDA.reportPublic FDA data

DENTALUX TOTAL CARE

Manufacturer
LIDL US, LLC | DENTAL-Kosmetik GmbH & Co. KG
Effective date
2019-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:18:09

Label at a glance#

ProductDENTALUX TOTAL CARE
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 Teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision. For children under 2 years of age: Consult a dentist o...

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 DENTAL CAVITIES

WARNINGS

WARNINGS SECTION

Keep out of reach of children under 6 years 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
  • Teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
  • For children under 2 years of age: Consult a dentist or physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, propylene glycol, glycerin, tetrapotassium pyrophosphate, xanthan gum, sodium C14-16 olefin sulfonate, flavor, allantoin, zinc chloride, sodium saccharin, calcium glycerophosphate, mica, iron oxodes, titanium dioxide, FD&Cblue no. 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dentalux Total Care_folding boxdentalux Total Care_folding box

dentalux Total Care_Tubedentalux Total Care_Tube

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-01571141-015-11, 71141-015-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
ALLANTOIN344S277G0ZIACT
ZINC CHLORIDE86Q357L16BIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CALCIUM GLYCEROPHOSPHATEXWV9Z12C1CIACT
MICAV8A1AW0880IACT
FERROUS OXIDEG7036X8B5HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
73834fdf-5f74-4dc7-8057-3c3693b7d98c731291ad-af30-4eda-85ea-5c3e007a18ba2019-07-27WarningsExact identifier
spl set id: 731291ad-af30-4eda-85ea-5c3e007a18ba

Reported adverse events (FAERS/openFDA)#

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