dentalux kids bubble gum by Lidl US LLC

dentalux kids bubble gum by

Drug Labeling and Warnings

dentalux kids bubble gum by is a Otc medication manufactured, distributed, or labeled by Lidl US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

pdp

DENTALUX KIDS BUBBLE GUM 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71141-172
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71141-172-32132 g in 1 TUBE; Type 0: Not a Combination Product05/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/09/2021
Labeler - Lidl US LLC (079389709)

Revised: 3/2023
 

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