DENTALUX COMPLEX 5- 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%

(0.15% 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.

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

dentalux whitening_layout folding box_2017

DENTALUX COMPLEX 5 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-113
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71141-113-001 in 1 BOX03/08/201710/03/2019
1NDC:71141-113-32157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/08/201710/03/2019
Labeler - LIDL US, LLC (079389709)
Establishment
NameAddressID/FEIBusiness Operations
DENTAL-Kosmetik GmbH & Co. KG330626300manufacture(71141-113)

Revised: 10/2020
Document Id: 7d098399-6a87-4b48-b565-a9d926725848
Set id: b2b89c43-6dd8-4933-9def-862621ab39b8
Version: 6
Effective Time: 20201003
 
LIDL US, LLC