Label: DENTALUX COMPLEX 5- sodium fluoride paste

  • NDC Code(s): 71141-113-00, 71141-113-32
  • Packager: LIDL US, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 7, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    SODIUM FLUORIDE 0.243%

    (0.15% W/V FLUORIDE ION)

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  • PURPOSE

    ANTICAVITY

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  • USE

    HELPS PROTECT AGAINST CAVITIES

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

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  • 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
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  • 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

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  • QUESTIONS?

    1-844-344-5071

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  • 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)
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