OLEA OLIDENTAL (SILICON DIOXIDE) PASTE [AJU PHARM CO., LTD.]

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OLEA OLIDENTAL (SILICON DIOXIDE) PASTE [AJU PHARM CO., LTD.]
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NDC 70417-002-01, 70417-002-02
Set ID 5167b6ee-90b7-4066-ae14-e518c7eafe50
Category HUMAN OTC DRUG LABEL
Packager AJU PHARM CO., LTD.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Silicon Dioxide 17%

  • PURPOSE

    Dental Care

  • INDICATIONS & USAGE

    To improve dental health and bad breath

  • DOSAGE & ADMINISTRATION

    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 physician

    Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

    Children under 2 years ask a dentist or physician

  • WARNINGS

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

  • INACTIVE INGREDIENT

    Aluminium Chlorohydroxy Allantoinate
    Aminocaproic Acid
    Chamomile Extract
    Eucalyptus Extract
    Sage Extract
    Aloe Extract
    Grapefruit Seed Extract
    Propolis Powder
    D-Sorbitol Solution
    Concentrated Glycerin
    Xantangum
    Xylitol
    Glucosyl Stevia
    Olive Leaf Extract
    Hydroxyapatite
    Sodium Cocoyl Glutamate
    Mint Flavor
    Begamot Flavor
    Solvent

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    OLEA OLIDENTAL 
    silicon dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70417-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE170 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCLOXA (UNII: 18B8O9DQA2)  
    AMINOCAPROIC ACID (UNII: U6F3787206)  
    CHAMOMILE (UNII: FGL3685T2X)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    CLARY SAGE (UNII: U3HSK5JC0Q)  
    ALOE (UNII: V5VD430YW9)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLUCOSYL STEVIOL (UNII: TKD5UC898Q)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70417-002-021 in 1 CARTON01/17/2017
    1NDC:70417-002-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/17/2017
    Labeler - AJU PHARM CO., LTD. (687982405)
    Registrant - AJU PHARM CO., LTD. (687982405)
    Establishment
    NameAddressID/FEIBusiness Operations
    AJU PHARM CO., LTD.687982405manufacture(70417-002)
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