Label: KUNDAL SENSITIVE DENTAL CARE TOOTH (APPLE CHAMOMILE MINT)- tribasic calcium phosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 15, 2020

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  • ACTIVE INGREDIENT

    Tricalcium Phosphate

  • INACTIVE INGREDIENT

    Sorbitol
    Water
    Sodium Cocoyl Glutamate
    Cellulose Gum
    PEG-32
    Apple chamomile mint flavor
    Menthol
    Sodium Benzoate
    Xylitol
    Stevioside
    Camellia Sinensis Leaf Extract
    Aloe Barbadensis Leaf Extract
    Chamomilla Recutita (Matricaria) Flower Extract
    Salvia Officinalis (Sage) Leaf Extract
    Eucalyptus Globulus Leaf Extract

  • PURPOSE

    for dental care

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

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

    Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

    Children under 2 years of age: Consult a dentist or doctor.

  • WARNINGS

    Do not swallow.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    KUNDAL SENSITIVE DENTAL CARE TOOTH (APPLE CHAMOMILE MINT) 
    tribasic calcium phosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0040
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74773-0040-12 in 1 BOX09/01/2020
    1150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2020
    Labeler - THESKINFACTORY Co., Ltd. (694804099)
    Registrant - THESKINFACTORY Co., Ltd. (694804099)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(74773-0040)
    Establishment
    NameAddressID/FEIBusiness Operations
    THESKINFACTORY Co., Ltd.694804099label(74773-0040)
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