Label: MONGDIES RASPBERRY BABY TOOTH- silicon dioxide paste, dentifrice

  • NDC Code(s): 70477-080-01, 70477-080-02
  • Packager: 360Perspective Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 10, 2021

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  • ACTIVE INGREDIENT

    Silicon Dioxide 15%

  • PURPOSE

    Anti-plaque

  • WARNINGS

    1. For babies under 3 years old. 2. Be careful not to swallow, and rinse mouth thoroughly after use. 3. If any abnormality occurs such as gums or mouth injuries with this toothpaste, discontinue use and consult a doctor or dentist.4. If a child under the age of 7 swallows a large amount, consult a doctor or dentist immediately. 5. Keep out of the reach of children under 7 years of age.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 7 years of age.

  • Uses

    It keeps the mouth clean and refresh the inside of the mouth. It prevents the cavity and removes plaque.

  • Directions

    Apply a rice sized amount and gently brush baby’s teeth.

  • INACTIVE INGREDIENTS

    D-Sorbitol Solution, Carboxymethylcellulose sodium, Xylitol, Steviol Glucoside, Sodium methyl cocoyl Taurate, Chitosan, Ascorbic Acid, Pyridoxine Hydrochloride, Rosemary Extract, Chamomile Extract(2), Strawberry Extract, Calendula Extract, Eucalyptus Oil, Orange Oil, Raspberry Flavor HF-AF11842, Purified Water

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MONGDIES RASPBERRY BABY TOOTH 
    silicon dioxide paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70477-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) Silicon Dioxide15.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    Xylitol (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70477-080-021 in 1 CARTON09/01/2021
    1NDC:70477-080-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2021
    Labeler - 360Perspective Inc. (689606142)
    Registrant - 360Perspective Inc. (689606142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(70477-080)
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