FDA.reportPublic FDA data

dentalux anticavity coconut

Manufacturer
Lidl US LLC | durodont GmbH
Effective date
2020-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:19:31

Label at a glance#

Productdentalux anticavity activated charcoal
Active ingredientSODIUM FLUORIDE
Label structure19 sections

Indications and uses

Uses Coconut tube Aids in the prevention of dental cavities Uses Coconut box Aids in the prevention of dental cavities

Dosage and administration

Directions Coconut tube adults and children 2 years of age and older: brush teeth thoroughly, prefereably 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 unter 6. teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision. children unter 2 years of age: consu...

Label contents#

Full prescribing information#

dentalux Coconut OTC Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

OTC Active Ingredient Coconut tube

Sodium fluoride 0,239% (0,15% w/v fluoride ion)

OTC Active ingredient Coconut tubeOTC Active ingredient Coconut tube

OTC Active Ingredient Coconut box

Sodium fluoride 0,239% (0,15% w/v fluoride ion)

OTC Active Ingredient Coconut boxOTC Active Ingredient Coconut box

dentalux Coconut OTC Purpose

OTC - PURPOSE SECTION

OTC Purpose Coconut tube

Anticavity

OTC Purpose Coco tubeOTC Purpose Coco tube

OTC Purpose Coconut box

Anticavity

OTC purpose Coco boxOTC purpose Coco box

dentalux Coconut Uses

INDICATIONS & USAGE SECTION

Uses Coconut tube

Aids in the prevention of dental cavities

Uses Coco tubeUses Coco tube

Uses Coconut box

Aids in the prevention of dental cavities

Uses Coco BoxUses Coco Box

dentalux Coconut OTC Warnings Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC Warnings Children Coconut tube

Keep out of reach of children under 6 years of age.

OTC Children Coco tubeOTC Children Coco tube

OTC Warnings Children Coconut box

Keep out of reach of children under 6 years of age.

OTC-Warning Children Coco boxOTC-Warning Children Coco box

dentalux Coconut Warnings

WARNINGS SECTION

Warnings Coconut tube

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.

Warnings tube CoconutWarnings tube Coconut

Warnings Coconut box

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.

Warnings box CoconutWarnings box Coconut

dentalux Coconut Directions

DOSAGE & ADMINISTRATION SECTION

Directions Coconut tube

  • adults and children 2 years of age and older: brush teeth thoroughly, prefereably 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 unter 6.
  • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
  • children unter 2 years of age: consult a dentist or doctor.

Directions Coconut tubeDirections Coconut tube

Directions Coconut box

  • adults and children 2 years of age and older: brush teeth thoroughly, prefereably 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 unter 6.
  • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
  • children unter 2 years of age: consult a dentist or doctor.

Directions coconut boxDirections coconut box

dentalux Coconut Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Coconut tube

sorbitol, water, hydrated silica, sodium bicarbonate, propylene glycol, tetrapotassium pyrophosphate, sodium C14-16 olefin sulfonate, disodium pyrophosphate, titanium dioxide, flavor, cellulose gum, sodium saccharin, zinc chloride, menthol.

Inactive ingredients Coco tubeInactive ingredients Coco tube

Inactive Ingredients Coconut box

sorbitol, water, hydrated silica, sodium bicarbonate, propylene glycol, tetrapotassium pyrophosphate, sodium C14-16 olefin sulfonate, disodium pyrophosphate, titanium dioxide, flavor, cellulose gum, sodium saccharin, zinc chloride, menthol.

Inactive Ingredients Coco boxInactive Ingredients Coco box

dentalux Coconut OTC Questions

OTC - QUESTIONS SECTION

OTC Questions Coconut tube

1-844-656-5151

OTC Questions Coco tubeOTC Questions Coco tube

OTC Questions Coconut box

1-844-656-5151

OTC Questions Coconut boxOTC Questions Coconut box

dentalux Activated Charcoal OTC Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

OTC Active Ingredient Charcoal tube

Sodium fluoride 0,239% (0,14% w/v fluoride ion)

OTC Active Ingredient Charcoal tubeOTC Active Ingredient Charcoal tube

OTC Active Ingredient Charcoal box

Sodium fluoride 0,239% (0,14% w/v fluoride ion)

OTC Active Ingredient Charcoal boxOTC Active Ingredient Charcoal box

dentalux Activated Charcoal OTC Purpose

OTC - PURPOSE SECTION

OTC Purpose Charchoal tube

Anticavity

OTC Purpose Charcoal tubeOTC Purpose Charcoal tube

OTC Purpose Charcoal box

Anticavity

OTC Purpose Charcoal boxOTC Purpose Charcoal box

dentalux Activated Charcoal Uses

INDICATIONS & USAGE SECTION

Uses Charcoal tube

Aids in the prevention of dental cavities

Uses Charcoal tuebUses Charcoal tueb

Uses Charcoal box

Aids in the prevention of dental cavities

Uses Charcoal boxUses Charcoal box

dentalux Activated Charcoal OTC Warnings Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC Warnings Children Charcoal tube

Keep out of reach of children under 6 years of age.

OTC-Warning Children Charcoal tubeOTC-Warning Children Charcoal tube

OTC Warnings Children Charcoal box

Keep out of reach of children under 6 years of age.

OTC-Warning Children Charcoal boxOTC-Warning Children Charcoal box

dentalux Activated Charcoal Warnings

WARNINGS SECTION

Warnings Charcoal tube

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.

Warnings tube CharcoalWarnings tube Charcoal

Warnings Charcoal box

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.

Warnings box CharcoalWarnings box Charcoal

dentalux Activated Charcoal Directions

DOSAGE & ADMINISTRATION SECTION

Directions Charcoal tube

  • adults and children 2 years of age and older: brush teeth thoroughly, prefereably 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 unter 6.
    • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
    • children unter 2 years of age: consult a dentist or doctor.

Direction Charcoal tubeDirection Charcoal tube

Directions Charcoal box

  • adults and children 2 years of age and older: brush teeth thoroughly, prefereably 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 unter 6.
  • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
  • children unter 2 years of age: consult a dentist or doctor.

Direction Charcoal boxDirection Charcoal box

dentalux Activated Charcoal Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Charcoal tube

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.

Inactive Ingredients Charcoal tubeInactive Ingredients Charcoal tube

Inactive Ingredients Charcoal box

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.

Inactive Ingredients Charcoal boxInactive Ingredients Charcoal box

dentalux Activated Charcoal OTC Questions

OTC - QUESTIONS SECTION

OTC Questions Charcoal tube

1-844-656-5151

OTC Questions Charcoal tubeOTC Questions Charcoal tube

OTC Questions Charcoal box

1-844-656-5151

OTC Questions Charcoal boxOTC Questions Charcoal box

Recent major changes

RECENT MAJOR CHANGES SECTION

none, new product

dentalux Coconut

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP Coconut tube

Anticavity toothpaste coconut NET WT 3.59 OZ (102 g)

PDP Coconut tubePDP Coconut tube

PDP Coconut box

Anticavity toothpaste coconut NET WT 3.59 OZ (102 g)

PDP Coconut boxPDP Coconut box

dentalux Activated Charcoal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP Charcoal tube

Anticavity toothpaste activated charcoal NET WT 3.34 OZ (94 g)

PDP tube CharcoalPDP tube Charcoal

PDP box charcoal

Anticavity toothpaste activated charcoal NET WT 3.34 OZ (94 g)

PDP box CharcoalPDP box Charcoal

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
71141-16571141-165-32, 71141-165-00
71141-16671141-166-32, 71141-166-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACTIVATED CHARCOAL2P3VWU3H10IACT
XANTHAN GUMTTV12P4NEEIACT
SORBITOL506T60A25RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ZINC CHLORIDE86Q357L16BIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
HYDRATED SILICAY6O7T4G8P9IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ZINC CHLORIDE86Q357L16BIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
HYDRATED SILICAY6O7T4G8P9IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

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
f0ff82a7-6dbf-11cf-e053-2a95a90ae540a4d39455-2ab7-8b95-e053-2a95a90a9d852022-12-29WarningsExact identifier
spl set id: a4d39455-2ab7-8b95-e053-2a95a90a9d85

Reported adverse events (FAERS/openFDA)#

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