DENTALUX COMPLEX 5- sodium fluoride paste

DENTALUX COMPLEX 5 by

Drug Labeling and Warnings

DENTALUX COMPLEX 5 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%

(0.15% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY

USE

HELPS PROTECT AGAINST CAVITIES

WARNINGS

Keep out of reach of children under 6 yrs. 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

• Remove foil seal before first use
• 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.
• 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 doctor.
• Do not swallow

INACTIVE INGREDIENTS

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

QUESTIONS?

1-844-344-5071

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTALUX COMPLEX 5 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-113
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)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)
ZINC CHLORIDE (UNII: 86Q357L16B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-113-00	1 in 1 BOX	03/08/2017
1	NDC: 71141-113-32	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	03/08/2017

Labeler - LIDL US, LLC (079389709)

Establishment
Name	Address	ID/FEI	Business Operations
DENTAL-Kosmetik GmbH & Co. KG		330626300	manufacture(71141-113)