Dentalux sensitive by Lidl US LLC

Dentalux sensitive by

Drug Labeling and Warnings

Dentalux sensitive by is a Otc medication manufactured, distributed, or labeled by Lidl US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DENTALUX SENSITIVE- potassium nitrate, 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

Potassium Nitrate 5%

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

Purpose

Antihypersensitivity

Anticavity

Uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
aids in the prevention of dental cavities

Keep out of reach of children

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Stop use and ask a dentist if
-the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist
-pain/sensitivity still persists after 4 weeks of use

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older:
- apply at least a 1-inch strip of the product onto a soft bristle toothbrush
- brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and no more than 3 times a day, or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing
- children under 12 years of age: consult a dentist or physician

Inactive Ingredients

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

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DENTALUX SENSITIVE 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-169
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
ALLANTOIN (UNII: 344S277G0Z)
ZINC CHLORIDE (UNII: 86Q357L16B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-169-32	159 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/01/2021

Labeler - Lidl US LLC (079389709)

Revised: 3/2023

Document Id: f81f6b52-92d3-4fe1-e053-6294a90acf8b

34390-5

Set id: bf4f33b4-8dde-c727-e053-2a95a90a8b9d

Version: 4

Effective Time: 20230330