Label: BEYOU PINK- toothpaste paste, dentifrice

  • 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 21, 2022

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

  • ACTIVE INGREDIENT

    Sodium monofluorophosphate 0.723%

    0.095 w/v fluoride ion

    Active ingredient

  • ASK DOCTOR

    Children under 6 years of age - Consult dentist or doctor

    Ask doctor

  • KEEP OUT OF REACH OF CHILDREN

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

    Keep from children

  • PURPOSE

    Fluoride toothpaste

    Purpose

  • WHEN USING

    Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

    When using

  • BOXED WARNING (What is this?)

    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.

    Warning

  • DOSAGE & ADMINISTRATION

    DosageA pea-sized amount of toothpaste is enough.
    Be gentle when brushing and use a toothbrush with soft, high-density bristles.

  • INACTIVE INGREDIENT

    Aqua, Glycerin, Hydrated silica, Sorbitol, Xylitol, Panthenol, Aroma, Xanthan gum, cocamidropropyl betaine, Microcrystalline cellulose, Decyl glucoside, Malodextrin, Hydroxyapatite (nano), Glucose oxidase, Mannitol, Mica, Sucralose, Citric acid, Sodium hydroxide, Zea mays starch, Glucose, Echinacea purpurea root extract, Titanium dioxide, Sodium chloride, D-limonene, Sodium metabisulfite, Calcium carbonate, L-methol, Centella asiatica extract, Citrus aurantium amara fruit extract, Potassium thiocyanate, Polylysine, Cetyl alcohol, Silica, Potassium chloride, Tin oxide, Harpagophytum procumbens root extract, CI 73360

    Inactive ingredients

  • INDICATIONS & USAGE

    Aides in the prevention of dental cavities.

    Indication

  • OTHER SAFETY INFORMATION

    Do not use if tamper proof seal is broken.

    Store at room temperature.

    Other

  • WARNINGS

    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

  • PRINCIPAL DISPLAY PANEL

    See artwork

    Artwork

  • INGREDIENTS AND APPEARANCE
    BEYOU PINK 
    toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71112-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.095 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM THIOCYANATE (UNII: TM7213864A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71112-002-211 in 1 BOX12/17/2021
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/17/2021
    Labeler - Curaden AG (481145555)
    Registrant - Trybol AG (480305077)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trybol AG480305077manufacture(71112-002)