dentalux charcoal by Lidl US LLC

Drug Details [pdf]

DENTALUX CHARCOAL- sodium fluoride paste, dentifrice
Lidl US LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

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

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Purpose

Anticavity

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Uses

aids in the prevention of dental cavities

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Keep out of reach of children

Keep out of reach of children under 6 years of age

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Warnings

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.

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Directions

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

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Inactive ingredient

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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Question

1-844-656-5151

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DENTALUX CHARCOAL
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-174
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.239 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC CHLORIDE (UNII: 86Q357L16B)
MENTHOL (UNII: L7T10EIP3A)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)

Product Characteristics
Color	black	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 71141-174-32	94 g in 1 TUBE; Type 0: Not a Combination Product	06/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/30/2021

Labeler - Lidl US LLC (079389709)

Revised: 3/2023

Document Id: f81f5efd-c318-e0bf-e053-6394a90aa029

Set id: c5e7fdeb-4b83-b14a-e053-2a95a90ad333

Version: 4

Effective Time: 20230330