DENTALUX KIDS BUBBLE GUM- sodium fluoride paste, dentifrice
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% (0.15% w/v fluoride ion)

active ingredient

Purpose

Anticavity

purpose

Uses

helps in the prevention of dental cavities

uses

Keep ot of reach of children

Keep out of reach of children under 6 years of age.

warnings

Warnings

Keep out of reach of childre 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.

warnings2

Directions

-Adults and children 2 years of age and olfer: brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentis or doctor do not swallow, to minimize swallowing, use a pea-sized amount in children under 6 years of age

-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 a doctor

directions

inactive ingredients

sorbitol, hydrated silica, water propylene glycol, sodium C14-16 olefin sulfonate, cellulose gum, flavor, limonene, calcium glycerophosphate, soium saccharin, mica, FD&C blue 1, titanium dioxide

inactive ingredients

pdp

DENTALUX KIDS BUBBLE GUM
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71141-172
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71141-172-32	132 g in 1 TUBE; Type 0: Not a Combination Product	05/09/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/09/2021

Labeler - Lidl US LLC (079389709)

Revised: 3/2023

Document Id: f81f6d80-075b-16a6-e053-6294a90ab148

Set id: c1e93abc-da80-f3e4-e053-2995a90af94e

Version: 3

Effective Time: 20230330

Lidl US LLC