Whitening Plus by Lidl US LLC

Drug Details [pdf]

WHITENING PLUS- 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 0.243% (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 of children

Keep out of reach of children unter 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

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 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: consult a dentist or doctor

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Inactive Ingredients

water, sorbitol, hydrated silica, propylene glycol, glycerin, pentasodium triphosphate, sodium C14-16 olefin sulfonate, flavor, xanthan gum, menthol, sodium saccharin, titanium dioxide

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WHITENING PLUS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-171
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
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 71141-171-32	159 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/04/2021

Labeler - Lidl US LLC (079389709)

Revised: 3/2023

Document Id: f81f6d80-0768-16a6-e053-6294a90ab148

Set id: c182a153-a1bb-a5aa-e053-2a95a90ab462

Version: 4

Effective Time: 20230330