Label: DENTALUX ANTICAVITY ACTIVATED CHARCOAL- sodium fluoride paste paste, dentifrice
DENTALUX ANTICAVITY COCONUT- sodium fluoride paste paste, dentifrice

  • NDC Code(s): 71141-165-00, 71141-165-32, 71141-166-00, 71141-166-32
  • 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 May 4, 2020

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

  • dentalux Coconut OTC Active Ingredient

    OTC Active Ingredient Coconut tube

    Sodium fluoride 0,239% (0,15% w/v fluoride ion)

    OTC Active ingredient Coconut tube

    OTC Active Ingredient Coconut box

    Sodium fluoride 0,239% (0,15% w/v fluoride ion)

    OTC Active Ingredient Coconut box

  • dentalux Coconut OTC Purpose

    OTC Purpose Coconut tube

    Anticavity

    OTC Purpose Coco tube

    OTC Purpose Coconut box

    Anticavity

    OTC purpose Coco box

  • dentalux Coconut Uses

    Uses Coconut tube

    Aids in the prevention of dental cavities

    Uses Coco tube

    Uses Coconut box

    Aids in the prevention of dental cavities

    Uses Coco Box

  • dentalux Coconut OTC Warnings Children

    OTC Warnings Children Coconut tube

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

    OTC Children Coco tube

    OTC Warnings Children Coconut box

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

    OTC-Warning Children Coco box

  • dentalux Coconut Warnings

    Warnings Coconut tube

    Keep out of reach of children 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.

    Warnings tube Coconut

    Warnings Coconut box

    Keep out of reach of children 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.

    Warnings box Coconut

  • dentalux Coconut Directions

    Directions Coconut tube

    • adults and children 2 years of age and older: brush teeth thoroughly, prefereably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children unter 6.
    • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
    • children unter 2 years of age: consult a dentist or doctor.

    Directions Coconut tube

    Directions Coconut box

    • adults and children 2 years of age and older: brush teeth thoroughly, prefereably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children unter 6.
    • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
    • children unter 2 years of age: consult a dentist or doctor.

    Directions coconut box

  • dentalux Coconut Inactive Ingredients

    Inactive Ingredients Coconut tube

    sorbitol, water, hydrated silica, sodium bicarbonate, propylene glycol, tetrapotassium pyrophosphate, sodium C14-16 olefin sulfonate, disodium pyrophosphate, titanium dioxide, flavor, cellulose gum, sodium saccharin, zinc chloride, menthol.

    Inactive ingredients Coco tube

    Inactive Ingredients Coconut box

    sorbitol, water, hydrated silica, sodium bicarbonate, propylene glycol, tetrapotassium pyrophosphate, sodium C14-16 olefin sulfonate, disodium pyrophosphate, titanium dioxide, flavor, cellulose gum, sodium saccharin, zinc chloride, menthol.

    Inactive Ingredients Coco box

  • dentalux Coconut OTC Questions

    OTC Questions Coconut tube

    1-844-656-5151

    OTC Questions Coco tube

    OTC Questions Coconut box

    1-844-656-5151

    OTC Questions Coconut box

  • dentalux Activated Charcoal OTC Active Ingredient

    OTC Active Ingredient Charcoal tube

    Sodium fluoride 0,239% (0,14% w/v fluoride ion)

    OTC Active Ingredient Charcoal tube

    OTC Active Ingredient Charcoal box

    Sodium fluoride 0,239% (0,14% w/v fluoride ion)

    OTC Active Ingredient Charcoal box

  • dentalux Activated Charcoal OTC Purpose

    OTC Purpose Charchoal tube

    Anticavity

    OTC Purpose Charcoal tube

    OTC Purpose Charcoal box

    Anticavity

    OTC Purpose Charcoal box

  • dentalux Activated Charcoal Uses

    Uses Charcoal tube

    Aids in the prevention of dental cavities

    Uses Charcoal tueb

    Uses Charcoal box

    Aids in the prevention of dental cavities

    Uses Charcoal box

  • dentalux Activated Charcoal OTC Warnings Children

    OTC Warnings Children Charcoal tube

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

    OTC-Warning Children Charcoal tube

    OTC Warnings Children Charcoal box

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

    OTC-Warning Children Charcoal box

  • dentalux Activated Charcoal Warnings

    Warnings Charcoal tube

    Keep out of reach of children 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.

    Warnings tube Charcoal

    Warnings Charcoal box

    Keep out of reach of children 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.

    Warnings box Charcoal

  • dentalux Activated Charcoal Directions

    Directions Charcoal tube

    • adults and children 2 years of age and older: brush teeth thoroughly, prefereably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • do not swallow
      • to minimize swallowing use a pea-sized amount in children unter 6.
      • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
      • children unter 2 years of age: consult a dentist or doctor.

    Direction Charcoal tube

    Directions Charcoal box

    • adults and children 2 years of age and older: brush teeth thoroughly, prefereably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children unter 6.
    • teach children under 6 years of age good brushing and rinsing habits until capable of using without supervision.
    • children unter 2 years of age: consult a dentist or doctor.

    Direction Charcoal box

  • dentalux Activated Charcoal Inactive Ingredients

    Inactive Ingredients Charcoal tube

    water, sorbitol, hydrated silica, propylene glycol, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium C14-16 olefin sulfonate, flavor, disodium pyrophosphate, xanthan gum, charcoal powder, zinc chloride, sodium saccharin, menthol.

    Inactive Ingredients Charcoal tube

    Inactive Ingredients Charcoal box

    water, sorbitol, hydrated silica, propylene glycol, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium C14-16 olefin sulfonate, flavor, disodium pyrophosphate, xanthan gum, charcoal powder, zinc chloride, sodium saccharin, menthol.

    Inactive Ingredients Charcoal box

  • dentalux Activated Charcoal OTC Questions

    OTC Questions Charcoal tube

    1-844-656-5151

    OTC Questions Charcoal tube

    OTC Questions Charcoal box

    1-844-656-5151

    OTC Questions Charcoal box

  • dentalux Coconut

    PDP Coconut tube

    Anticavity toothpaste coconut NET WT 3.59 OZ (102 g)

    PDP Coconut tube

    PDP Coconut box

    Anticavity toothpaste coconut NET WT 3.59 OZ (102 g)

    PDP Coconut box

  • dentalux Activated Charcoal

    PDP Charcoal tube

    Anticavity toothpaste activated charcoal NET WT 3.34 OZ (94 g)

    PDP tube Charcoal

    PDP box charcoal

    Anticavity toothpaste activated charcoal NET WT 3.34 OZ (94 g)

    PDP box Charcoal

  • INGREDIENTS AND APPEARANCE
    DENTALUX ANTICAVITY ACTIVATED CHARCOAL 
    sodium fluoride paste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-165
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION243 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblackScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71141-165-001 in 1 BOX08/03/2020
    1NDC:71141-165-3294 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/03/2020
    DENTALUX ANTICAVITY COCONUT 
    sodium fluoride paste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-166
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION243 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCOCONUTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71141-166-001 in 1 BOX08/03/2020
    1NDC:71141-166-32102 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/03/2020
    Labeler - Lidl US LLC (079389709)
    Registrant - durodont GmbH (341254136)