DENTALUX SENSITIVE- sodium fluoride paste

DENTALUX TOTAL CARE by

Drug Labeling and Warnings

DENTALUX TOTAL CARE by is a Otc medication manufactured, distributed, or labeled by LIDL US, LLC, DENTAL-Kosmetik GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

POTASSIUM NITRATE 5%

SODIUM FLUORIDE 0.243%

(0.14% W/V FLUORIDE ION)

PURPOSE

ANTIHYPERSENSITIVITY

ANTICAVITY

USE

• BUILDS INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH TO COLD, HEAT, ACIDS, SWEETS, OR CONTACT.
• AIDS IN THE PREVENTION OF DENTAL CAVITIES.

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

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 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 sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
• Children under 12 years of age: ask a dentist or physician.

INACTIVE INGREDIENTS

water, sorbitol, hydrated silica, propylene glycol, glycerin, sodium C14-16 olefin sulfonate, xanthan gum, flavor, tetrapotassium pyrophosphate, allantoin, zinc chloride, sodium saccharin, titanium dioxide, FD&C Blue no. 1, D&C yellow no. 10

STORAGE AND HANDLING

STORE IN A COOL, DRY PLACE. REMOVE FOIL SEAL BEFORE FIRST USE.

QUESTIONS?

1-844-344-5071

WWW.LIDL.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTALUX SENSITIVE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-164
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

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z)	5 g  in 100 g
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
ALLANTOIN (UNII: 344S277G0Z)
ZINC CHLORIDE (UNII: 86Q357L16B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-164-00	1 in 1 BOX	07/24/2019
1	NDC: 71141-164-32	155 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/24/2019

Labeler - LIDL US, LLC (079389709)

Establishment
Name	Address	ID/FEI	Business Operations
DENTAL-Kosmetik GmbH & Co. KG		330626300	manufacture(71141-164)