Dentalux total care by Lidl US LLC

Drug Details [pdf]

DENTALUX TOTAL CARE- 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 Ingredients

Sodium fluoride 0,243% (0,14% w/v fluoride ion)

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Purpose

Anticavity

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Uses

helps protect against dental cavities

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Keep out of reach

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.

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Warnings

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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 use as directed by a dentist or doctor

- do not swallow

- to minimize swallowing use a pea-sized amount in children under 6 years of age

- teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision

Children under 2 years of age: cosult a dentist or doctor

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Inactive ingredients

water, sorbitol, hydrated silica, propylene glycol, potassium nitrate, glycerin, sodium C14-16 olefin sulfonate, flavor, xanthan gum, menthol, sodium saccharin, zinc chloride, titanium dioxide

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DENTALUX TOTAL CARE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-170
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ZINC CHLORIDE (UNII: 86Q357L16B)
SORBITOL (UNII: 506T60A25R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM NITRATE (UNII: RU45X2JN0Z)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 71141-170-32	159 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/01/2021

Labeler - Lidl US LLC (079389709)

Revised: 3/2023

Document Id: f81f6d80-0772-16a6-e053-6294a90ab148

Set id: c17f010a-f73d-5191-e053-2a95a90af468

Version: 4

Effective Time: 20230330