Label: BEYOU ORANGE- 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 July 12, 2022

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

  • Active Ingredient(s)

    Sodium monofluorophosphate 0.723%
    (0.095% W/V fluoride ion)

  • Purpose

    Fluoride toothpaste

  • Use

    Aids in the prevention of dental cavities.

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • Directions

    Adults and children 2 years of age and older: Brush teeth thoroughly, preferably afler each meal or at least twice a day, or as directed by a dentist or doctor

    Children under 6 years of age: Instructin good brushing and rising habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision

    Children under 6 years of age: Consult dentist or doctor

  • Other information

    Do nont use if tamper proof seal is broken

    Store at room temperature.

  • Inactive ingredients

    AQUA, GLYCERIN, HYDRATED SILICA, SORBITOL, XYLITOL, PANTHENOL, AROMA, XANTHAN GUM, COCAMIDOPROPYL BETAINE, MICROCRYSTALLINE CELlLn.OSE, DECYL GLUCOSIDE, HYDROXYAPATITE (NANO), GLUCOSE OXIDASE, MANNITOL. MALTODEXTRIN, MICA, SUCRALOSE, CITRIC ACID, SODIUM HYDROXIDE, ZEA MAYS STARCH, ECHINACEA PURPUREA ROOT EXTRACT, TITANIUM DIOXIDE, SODIUM CHLORIDE, D-LIMONENE, SODIUM METABISULFITE, GLUCOSE, CALCIUM CARBONATE, L-MENTHOL, CENTELLAASIATICAEXTRACT, CITRUSAURANTIUM AMARA FRUIT EXTRACT, POTASSIUM THIOCYANATE, POLYLYSINE, CETYL ALCOHOL, LINALOOL, SILICA, POTASSIUM CHLORIDE, TIN OXIDE, HARPAGOPHYTI.JM PROCUMBENS ROOT EXTRACT,
    Cl77492,CITT491

  • DOSAGE & ADMINISTRATION

    A pea-sized amount of toothpaste is enough. For the best whitening results: Do not rinse your mouth afterwards. Be gentle when brushing and use a toothbrush with soft, high-density bristles. Once a day, brush between your teeth with an interdental brush to keep your gums and teeth healthier, and your breath fresher.

  • PRINCIPAL DISPLAY PANEL

    Active Ingredients

    Purpose

    Use

    Warning

    OTC - Keep out of reach of children

    Directions

    Other Information

    Inactive Ingredients

    Dose and administration

    Curaden Package Label Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    BEYOU ORANGE 
    toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71112-003
    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
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM THIOCYANATE (UNII: TM7213864A)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEACH (Peach + Apricot flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71112-003-201 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 - Curaden AG (481145555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trybol AG480305077manufacture(71112-003)