DENTALUX TOTAL CARE by LIDL US, LLC / DENTAL-Kosmetik GmbH & Co. KG

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]

DENTALUX TOTAL CARE- sodium fluoride paste 
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)

PURPOSE

ANTICAVITY

USE

HELPS 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.

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.
• For 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 oxodes, titanium dioxide, FD&Cblue no. 1

QUESTIONS?

1-844-344-5071

www.lidl.com

DENTALUX TOTAL CARE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-015
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
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)
FERROUS OXIDE (UNII: G7036X8B5H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-015-51	1 in 1 BOX	07/24/2019
1	NDC: 71141-015-11	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	07/27/2019

Labeler - LIDL US, LLC (079389709)

Establishment
Name	Address	ID/FEI	Business Operations
DENTAL-Kosmetik GmbH & Co. KG		330626300	manufacture(71141-015)

Revised: 7/2019

Document Id: 73834fdf-5f74-4dc7-8057-3c3693b7d98c

34390-5

Set id: 731291ad-af30-4eda-85ea-5c3e007a18ba

Version: 2

Effective Time: 20190727

 

LIDL US, LLC