dentalux coconut minerals by Lidl US LLC

Drug Details [pdf]

DENTALUX COCONUT MINERALS- 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% (0.15% 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 a 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
childred under 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 ingredients

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.

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Questions

1-844-656-5151

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DENTALUX COCONUT MINERALS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-175
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
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ZINC CHLORIDE (UNII: 86Q357L16B)
MENTHOL (UNII: L7T10EIP3A)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
WATER (UNII: 059QF0KO0R)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape		Size
Flavor	COCONUT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 71141-175-00	1 in 1 BOX	06/30/2021
1	NDC: 71141-175-32	102 g in 1 TUBE; Type 0: Not a Combination Product

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: f81f60fc-6cd1-3b40-e053-6394a90a5cd1

Set id: c60f7935-850c-bda8-e053-2995a90a9e36

Version: 4

Effective Time: 20230330