DENTALUX TOTAL CARE- 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

SODIUM FLUORIDE 0.243%

(0.14% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY

USE

• HELP PROTECT AGAINST DENTAL CAVITIES.

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

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 physician.
• Do not swallow
• To minimize swallowing use a pea-sized amount in children 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 physician.

INACTIVE INGREDIENTS

water, hydrated silica, sorbitol, propylene glycol, glycerin, tetrapotassium pyrophosphate, xanthan gum, sodium C14-16 olefin sulfonate, flavor, allantoin, zinc chloride, sodium saccharin, calcium glycerophosphate, mica, iron oxides, titanium dioxide, FD&C blue no. 1

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 TOTAL CARE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-163
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
ALLANTOIN (UNII: 344S277G0Z)
ZINC CHLORIDE (UNII: 86Q357L16B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-163-00	1 in 1 BOX	07/24/2019
1	NDC: 71141-163-32	157 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(71141-163)