DENTALUX KIDS ANTICAVITY FLUORIDE TOOTH BUBBLE GUM- sodium fluoride paste

DENTALUX KIDS ANTICAVITY FLUORIDE TOOTH by

Drug Labeling and Warnings

DENTALUX KIDS ANTICAVITY FLUORIDE TOOTH 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

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

• 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
• Supervise children until good brushing and rinsing habits are established.
• For children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENTS

water, sorbitol, hydrated silica, propylene glycol, sodium C14-16 olefin sulfonate, xanthan gum, flavor, sodium saccharin, tocopheryl acetate, sodium methylparaben, mica, titanium dioxide, iron oxides, FD&C blue no. 1

QUESTIONS?

1-844-656-5151

www.lidl.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTALUX KIDS ANTICAVITY FLUORIDE TOOTH  BUBBLE GUM
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-162
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)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-162-32	126 g in 1 TUBE; Type 0: Not a Combination Product	04/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/24/2019

Labeler - LIDL US, LLC (079389709)

Establishment
Name	Address	ID/FEI	Business Operations
DENTAL-Kosmetik GmbH & Co. KG		330626300	manufacture(71141-162)