FDA.reportPublic FDA data

dentalux charcoal

Manufacturer
Lidl US LLC
Effective date
2023-03-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:33:34

Label at a glance#

Productdentalux charcoal
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

aids in the prevention of dental cavities tube: box:

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 as directed by a dentist or doctor. do not swallow to minimize swallowing use a pea-sized amount in children und 6 teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision children under 2 years of age: consult a dentist or doctor tube: ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride 0.239% (0.14% w/v fluoride ion)

tube: active ingredient tubeactive ingredient tube

box: active ingredient boxactive ingredient box

Purpose

OTC - PURPOSE SECTION

Anticavity

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box: purpose boxpurpose box

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

tube: uses_tubeuses_tube

box: uses_boxuses_box

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

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box:

keep out of reach_boxkeep out of reach_box

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 Poison Control Center right away.

tube: warnings_tubewarnings_tube

box: warnings_boxwarnings_box

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 as directed by a dentist or doctor.
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children und 6
  • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision
  • children under 2 years of age: consult a dentist or doctor

tube: directions_tubedirections_tube

box:

directions_boxdirections_box

Inactive ingredient

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, propylene glycol, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium C14-16 olefin sulfonate, flavor, disodium pyrophosphate, xanthan gum, charcoal powder, zinc chloride, sodium saccharin, menthol.

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box: inactive ingredients_boxinactive ingredients_box

Question

OTC - QUESTIONS SECTION

1-844-656-5151

tube: questions tubequestions tube

box: directions_boxdirections_box

pdp

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp tube:

pdp_tubepdp_tube

pdp box:

pdp_boxpdp_box

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-17471141-174-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACTIVATED CHARCOAL2P3VWU3H10IACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC CHLORIDE86Q357L16BIACT
MENTHOLL7T10EIP3AIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
f81f5efd-c318-e0bf-e053-6394a90aa029c5e7fdeb-4b83-b14a-e053-2a95a90ad3332023-03-30WarningsExact identifier
spl id: f81f5efd-c318-e0bf-e053-6394a90aa029
spl set id: c5e7fdeb-4b83-b14a-e053-2a95a90ad333

Reported adverse events (FAERS/openFDA)#

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